GERIATRIC USE SECTION.

8.5 Geriatric Use. Clinical trials of VERDESO Foam did not include any subjects aged 65 or over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. The most common adverse reactions (>1%) are upper respiratory tract infection, cough, application site burning, headache, viral infection, and increased blood pressure. (6.1)In post-marketing reports, the most common adverse reactions were application site irritation followed by application site erythema. (6.2)To report SUSPECTED ADVERSE REACTIONS, contact Almirall at 1-866-665-2782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.. The most common adverse reactions (>1%) are upper respiratory tract infection, cough, application site burning, headache, viral infection, and increased blood pressure. (6.1). In post-marketing reports, the most common adverse reactions were application site irritation followed by application site erythema. (6.2). 6.1 Clinical Trial Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In controlled clinical trial of 581 subjects aged months to 17 years, adverse reactions occurred at the application site in 6% of subjects treated with VERDESO Foam and 14% of subjects treated with vehicle foam. Other commonly reported adverse reactions for VERDESO Foam and vehicle foam are noted in Table 1.Table 1. Adverse Reactions in the Clinical TrialAdverse ReactionVERDESO Foam(N 387)Vehicle(N 194)Upper respiratory tract infection37 (10%)12 (6%)Cough14 (4%)3 (2%)Application site burning11 (3%)15 (8%)Viral infection6 (2%)0 (0%)Elevated blood pressure6 (2%)1 (1%)Headache7 (2%)1 (1%)Asthma3 (1%)0 (0%)Irritability2 (1%)0 (0%)Pharyngitis2 (1%)0 (0%)Application site atrophy5 (1%)0 (0%)Application site reactions (including atrophy, striae, telangiectasia and pigmentation changes)3 (1%)6 (3%)Other local adverse events occurred at rates less than 1.0%. The majority of adverse reactions were transient and mild to moderate in severity, and they were not affected by age, race, or gender. The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.. 6.2 Post-marketing Experience. Because these reactions are reported voluntarily from population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.The following adverse reactions have been identified during post-approval use of VERDESO Foam: application site irritation, application site erythema, skin reactions, and swelling face.Ophthalmic adverse reactions of blurred vision, cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term animal studies have not been performed to evaluate the carcinogenic potential of VERDESO Foam or desonide.In 90-day repeat-dose toxicity study in rats, topical administration of VERDESO Foam at dose concentrations from 0.025% to 0.125% (providing 0.075 to 0.375 mg/kg/day of desonide) resulted in toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.Desonide revealed no evidence of mutagenic potential based on the results of in vitro genotoxicity tests (Ames assay, mouse lymphoma cell assay) and an in vivo genotoxicity test (mouse micronucleus assay).The effects of desonide on fertility have not been evaluated.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. Corticosteroids play role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in the treatment of atopic dermatitis is unknown.The contribution to efficacy by individual components of the vehicle has not been established.. 12.2 Pharmacodynamics. In an HPA axis suppression trial, three of 75 (4%) pediatric subjects with mild to moderate atopic dermatitis covering at least 25% body surface area, who applied VERDESO Foam twice daily, experienced reversible suppression of the adrenal glands (as indicated by 30-minute post-stimulation cortisol level 18 mcg/dL) following weeks of therapy. [See also Hypothalamic-Pituitary-Adrenal Axis Suppression (5.1) and Pediatric Use (8.4)]. 12.3 Pharmacokinetics. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation, the integrity of the epidermal barrier, and age. Occlusion, inflammation, and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized primarily in the liver and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

CLINICAL STUDIES SECTION.

14 CLINICAL STUDIES. In double-blind, randomized trial of 581 subjects aged months to 17 years, with mild to moderate atopic dermatitis, VERDESO Foam was applied twice daily for weeks. Success was defined as the proportion of subjects who had all of the following: an Investigators Static Global Assessment (ISGA) score of clear or almost clear, minimum improvement in the 5-point ISGA score of grades from Baseline to Week 4, and score of absent or minimal for both erythema and induration/papulation at Week 4. The results of this trial are presented in the following table.Table 2. Results of Clinical Trial in Subjects Aged Months to 17 Years With Mild to Moderate Atopic DermatitisVERDESO FoamVehicle FoamNumber of Patients387194Patients Achieving Success152 (39%)18 (9%).

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. None.. None. (4). None. (4).

DESCRIPTION SECTION.

11 DESCRIPTION. VERDESO Foam is white to off-white petrolatum-based emulsion aerosol foam containing the active ingredient desonide, low-potency topical corticosteroid.Chemically, desonide is (11,16)-11,21-dihydroxy-16,17-[(1-methylethylidene)-bis(oxy)]-pregna-1,4-diene-3,20-dione. The structural formula of desonide is represented below:Desonide has molecular formula of C24H32O6 and molecular weight of 416.51. Desonide is white powder or crystal that is practically insoluble in water, sparingly soluble in ethanol and in acetone, and soluble in chloroform. Each gram of VERDESO Foam contains 0.5 mg desonide. The foam also contains anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, potassium citrate (monohydrate), propylene glycol, purified water, sorbitan monolaurate, and phenoxyethanol as preservative.VERDESO Foam is dispensed from an aluminum can pressurized with hydrocarbon (propane/butane) propellant.. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. VERDESO Foam is not for oral, ophthalmic, or intravaginal use.A thin layer of VERDESO Foam should be applied to the affected area(s) twice daily. Shake the can before use. VERDESO Foam should be dispensed by inverting the can (upright actuation will cause loss of the propellant which may affect product delivery). Dispense the smallest amount of foam necessary to adequately cover the affected area(s) with thin layer.The medication should not be dispensed directly on the face. Dispense in hands and gently massage into affected areas of the face until the medication disappears. For areas other than the face, the medication may be dispensed directly onto the affected area. Take care to avoid contact with the eyes or other mucous membranes.Therapy should be discontinued when control is achieved. If no improvement is seen within weeks, reassessment of diagnosis may be necessary. The safety and efficacy of VERDESO Foam has not been established beyond weeks of use. Unless directed by physician, VERDESO Foam should not be used with occlusive dressings.. VERDESO Foam should be applied to the affected area(s) twice daily. (2)Discontinue therapy when control has been achieved. (2)If no improvement is seen within weeks, reassess diagnosis. (2)Unless directed by physician, do not use with occlusive dressings. (2)VERDESO Foam is not for oral, ophthalmic, or intravaginal use. (2)The safety and efficacy of VERDESO Foam has not been established beyond weeks of use. (2). VERDESO Foam should be applied to the affected area(s) twice daily. (2). Discontinue therapy when control has been achieved. (2). If no improvement is seen within weeks, reassess diagnosis. (2). Unless directed by physician, do not use with occlusive dressings. (2). VERDESO Foam is not for oral, ophthalmic, or intravaginal use. (2). The safety and efficacy of VERDESO Foam has not been established beyond weeks of use. (2).

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. Foam, 0.05%. Each gram of VERDESO Foam contains 0.5 mg of desonide in white to off-white petrolatum-based emulsion aerosol foam.. Foam, 0.05% (3). Foam, 0.05% (3).

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING. 16.1 How Supplied. VERDESO Foam is white to off-white aerosol foam supplied in 100-g (NDC 16110-111-00) aluminum cans.. 16.2 Storage and Handling. Store at USP controlled room temperature 68F to 77F (20C to 25C) with excursions permitted between 15C (59F) and 30C (86F). WARNING: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose containers to heat, and/or store at temperatures above 120F (49C). Avoid contact with eyes or other mucous membranes.Keep out of reach of children.

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. VERDESO(R) (desonide) Foam, 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients months of age and older.Patients should be instructed to use VERDESO Foam for the minimum amount of time necessary to achieve the desired results because of the potential for VERDESO Foam to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Treatment should not exceed consecutive weeks.. VERDESO Foam is corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients months of age and older. (1). VERDESO Foam is corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients months of age and older. (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. See FDA-Approved Patient Labeling (Patient Information).Important Administration InstructionsInform patients of the following:This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes or other mucous membranes. The medication should not be dispensed directly onto the face. Dispense in hands and gently massage into affected areas of the face until the medication disappears. For areas other than the face, the medication may be dispensed directly on the affected area. Wash hands after use.Advise patients to report any visual symptoms to their healthcare providers.This medication should not be used for any disorder other than that for which it was prescribed.The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physicianPatients should report any signs of local or systemic adverse reactions to the physician.Patients should inform their physicians that they are using VERDESO Foam if surgery is contemplated.Therapy should be discontinued when control is achieved. If no improvement is seen within weeks, contact the physician.Do not use other corticosteroid-containing products while using VERDESO Foam without first consulting your physician.The propellant in VERDESO Foam is flammable. Avoid fire, flame or smoking during and immediately following application. LactationAdvise woman to use VERDESO Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women to wash off any VERDESO Foam that has been applied to the nipple and areola prior to breastfeeding to avoid direct infant exposure [see Use in Specific Populations (8.2)]. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes or other mucous membranes. The medication should not be dispensed directly onto the face. Dispense in hands and gently massage into affected areas of the face until the medication disappears. For areas other than the face, the medication may be dispensed directly on the affected area. Wash hands after use.. Advise patients to report any visual symptoms to their healthcare providers.. This medication should not be used for any disorder other than that for which it was prescribed.. The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician. Patients should report any signs of local or systemic adverse reactions to the physician.. Patients should inform their physicians that they are using VERDESO Foam if surgery is contemplated.. Therapy should be discontinued when control is achieved. If no improvement is seen within weeks, contact the physician.. Do not use other corticosteroid-containing products while using VERDESO Foam without first consulting your physician.. The propellant in VERDESO Foam is flammable. Avoid fire, flame or smoking during and immediately following application.

LACTATION SECTION.

8.2 Lactation. Risk SummaryThere are no data on the presence of desonide in human or animal milk, its effects on the breastfed infant, or its effects on milk production.It is not known whether topical administration of VERDESO Foam could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for VERDESO Foam and any potential adverse effects on the breastfed infant from VERDESO Foam or from the underlying maternal condition.Clinical ConsiderationsTo minimize potential exposure to the breastfed infant via breast milk, use VERDESO Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women to wash off any VERDESO Foam that has been applied to the nipple and areola prior to breastfeeding to avoid direct infant exposure.

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. Corticosteroids play role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in the treatment of atopic dermatitis is unknown.The contribution to efficacy by individual components of the vehicle has not been established.

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term animal studies have not been performed to evaluate the carcinogenic potential of VERDESO Foam or desonide.In 90-day repeat-dose toxicity study in rats, topical administration of VERDESO Foam at dose concentrations from 0.025% to 0.125% (providing 0.075 to 0.375 mg/kg/day of desonide) resulted in toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections. no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.Desonide revealed no evidence of mutagenic potential based on the results of in vitro genotoxicity tests (Ames assay, mouse lymphoma cell assay) and an in vivo genotoxicity test (mouse micronucleus assay).The effects of desonide on fertility have not been evaluated.

OVERDOSAGE SECTION.

10 OVERDOSAGE. Topically applied VERDESO Foam can be absorbed in sufficient amounts to produce systemic effects.Because of higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of HPA axis suppression and Cushings syndrome when they are treated with topical corticosteroids.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL NDC: 16110-111-00 Can Label. Can Label.

PEDIATRIC USE SECTION.

8.4 Pediatric Use. Safety and efficacy in pediatric patients younger than months have not been established; therefore, the use of VERDESO Foam is not recommended.Because of higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of HPA axis suppression and Cushings syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriateuse of topical corticosteroids in infants and children. HPA axis suppression, Cushings syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroidsto children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.The effect of VERDESO Foam on HPA axis function was investigated in pediatric subjects, aged months to 17 years in one trial. In this trial, subjects with atopic dermatitis covering at least 25% of their body applied VERDESO Foam twice daily for weeks. Three out of 75 subjects (4%) displayed adrenal suppression after weeks of use based on the ACTH stimulation test. The suppression was transient; all subjects cortisol levels had returned to normal when tested weeks post-treatment.

PHARMACODYNAMICS SECTION.

12.2 Pharmacodynamics. In an HPA axis suppression trial, three of 75 (4%) pediatric subjects with mild to moderate atopic dermatitis covering at least 25% body surface area, who applied VERDESO Foam twice daily, experienced reversible suppression of the adrenal glands (as indicated by 30-minute post-stimulation cortisol level 18 mcg/dL) following weeks of therapy. [See also Hypothalamic-Pituitary-Adrenal Axis Suppression (5.1) and Pediatric Use (8.4)].

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation, the integrity of the epidermal barrier, and age. Occlusion, inflammation, and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized primarily in the liver and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.

PREGNANCY SECTION.

8.1 Pregnancy. Risk SummaryThere are no available data on VERDESO Foam use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, topical administration of desonide cream, 0.05% formulation during organogenesis caused malformations characteristic of corticosteroids in rats and in rabbits (see Data). The available data do not allow the calculation of relevant comparisons between the systemic exposure of desonide observed in animal studies to the systemic exposure that would be expected in humans after topical use of VERDESO Foam.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.DataAnimal DataTopical administration of desonide cream, 0.05% formulation to pregnant rats (gestational days to 15) and pregnant rabbits (gestational days to 18) at 0.2, 0.6, and 2.0 cream/kg/day was associated with maternal body weight loss at all dose levels in both species. Malformations characteristic of corticosteroids were observed in rats at topical doses of >=0.6 cream/kg/day and in rabbits at topical dose of 2.0 cream/kg/day. No malformations were observed at topical dose of 0.2 cream/kg/day in rats and at topical dose of 0.6 cream/kg/day in rabbits.

SPL PATIENT PACKAGE INSERT SECTION.

FDA-Approved Patient LabelingPATIENT INFORMATIONVERDESO (ver-DES-o) (desonide) Foam 0.05%Read the Patient Information that comes with VERDESO Foam before you start using it and each time you get refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.What is VERDESO FoamVERDESO Foam is prescription medicine used on the skin (topical) to treat mild or moderate atopic dermatitis in people months of age and older.It is not known if VERDESO Foam is safe and effective when used for longer than weeks in row. You should not use VERDESO Foam for more than weeks in row without talking with your doctor.It is not known if VERDESO Foam is safe and effective in children younger than months of age.What should tell my doctor before using VERDESO FoamBefore using VERDESO Foam, tell your doctor if you:have skin infection that is not healing.have had irritation or other skin reaction to steroid medicine in the past.plan to have surgery.are pregnant or plan to become pregnant. It is not known if VERDESO Foam will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if VERDESO Foam passes into your breast milk. If you use VERDESO Foam while breastfeeding, do not apply it to your chest area. This will help prevent your baby from swallowing VERDESO Foam.Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you use another medicine on your skin for your atopic dermatitis.Know the medicines you take. Keep list of them to show your doctor and pharmacist when you get new medicine.How should use VERDESO FoamUse VERDESO Foam exactly as prescribed. Do not use more VERDESO Foam than is needed to cover the affected areas.Do not get VERDESO Foam in your eyes, mouth, or vagina.VERDESO Foam is usually applied to the affected skin areas times each day.Talk to your doctor if your skin does not improve after using VERDESO Foam for weeks.You should not use VERDESO Foam for more than weeks in row without talking with your doctorVERDESO Foam contains alcohol. Alcohol-based products are flammable. Avoid fire, flames, or smoking while applying VERDESO Foam to your skin and right after you apply it.Applying VERDESO Foam.Before applying VERDESO Foam for the first time, break the tiny plastic seal at the base of the nozzle by gently pushing it back away from the seal. Shake the can before use. Remove the cap.Turn the can upside down. Depress the button to dispense small amount of VERDESO Foam into the palm of your hand or directly onto the affected skin area. Do not apply VERDESO Foam directly to your face. Use the smallest amount of VERDESO Foam needed to cover the affected areas with thin layer.Gently massage the VERDESO Foam into the affected areas until it disappears. Avoid getting the medicine in your eyes.Do not apply directly on the face. Place in hands and gently massage affected areas of face. Take care to avoid eyes and lips. Remember to wash hands after use.Do not apply bandage over VERDESO Foam unless your doctor tells you to.What are the possible side effects of VERDESO FoamCommon side effects of VERDESO Foam include:upper respiratory tract infectionburning where you apply VERDESO Foamcoughheadacheincreased blood pressureTell your doctor if you have any side effects that bother you or that do not go away.These are not all the possible side effects of VERDESO Foam. Ask your doctor or pharmacist for more information.Call your doctor for medical advice about side effects. You may report side effects to Almirall at 1-866-665-2782 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.How should store VERDESO FoamStore the can of VERDESO Foam at room temperature, 68 to 77F (20 to 25C).Do not place the can of VERDESO Foam in the refrigerator or freezer.Do not expose containers to heat, and/or store at temperatures above 120F (49C).Do not break through (puncture) the can of VERDESO Foam.VERDESO Foam is flammable. Avoid fire, flame, or smoking during and immediately following application.Keep VERDESO Foam and all medicines out of the reach of children.General information about VERDESO FoamDo not use VERDESO Foam for condition for which it was not prescribed. Do not give VERDESO Foam to other people, even if they have the same symptoms that you have. It may harm them.This leaflet summarizes the most important information about VERDESO Foam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about VERDESO Foam that is written for health professionals.What are the ingredients in VERDESO FoamActive ingredient: desonideInactive Ingredients: anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, potassium citrate (monohydrate), propylene glycol, purified water, sorbitan monolaurate, and phenoxyethanol as preservative. The can is pressurized with hydrocarbon (propane/butane) propellant.This Patient Information has been approved by the U.S. Food and Drug Administration. VERDESO is registered trademark of StiefelLaboratories, Inc.Manufactured by DPT Laboratories, San Antonio, TX 78215For Almirall, LLC, 101 Lindenwood Drive, Suite 400, Malvern, PA 19355(C)2019, Almirall, LLCAll rights reserved.Revised: 04/2019. have skin infection that is not healing.. have had irritation or other skin reaction to steroid medicine in the past.. plan to have surgery.. are pregnant or plan to become pregnant. It is not known if VERDESO Foam will harm your unborn baby.. are breastfeeding or plan to breastfeed. It is not known if VERDESO Foam passes into your breast milk. If you use VERDESO Foam while breastfeeding, do not apply it to your chest area. This will help prevent your baby from swallowing VERDESO Foam.. Use VERDESO Foam exactly as prescribed. Do not use more VERDESO Foam than is needed to cover the affected areas.. Do not get VERDESO Foam in your eyes, mouth, or vagina.. VERDESO Foam is usually applied to the affected skin areas times each day.. Talk to your doctor if your skin does not improve after using VERDESO Foam for weeks.. You should not use VERDESO Foam for more than weeks in row without talking with your doctor. VERDESO Foam contains alcohol. Alcohol-based products are flammable. Avoid fire, flames, or smoking while applying VERDESO Foam to your skin and right after you apply it.. Before applying VERDESO Foam for the first time, break the tiny plastic seal at the base of the nozzle by gently pushing it back away from the seal. Shake the can before use. Remove the cap.. Turn the can upside down. Depress the button to dispense small amount of VERDESO Foam into the palm of your hand or directly onto the affected skin area. Do not apply VERDESO Foam directly to your face. Use the smallest amount of VERDESO Foam needed to cover the affected areas with thin layer.. Gently massage the VERDESO Foam into the affected areas until it disappears. Avoid getting the medicine in your eyes.. Do not apply directly on the face. Place in hands and gently massage affected areas of face. Take care to avoid eyes and lips. Remember to wash hands after use.. Do not apply bandage over VERDESO Foam unless your doctor tells you to.. upper respiratory tract infection. burning where you apply VERDESO Foam. cough. headache. increased blood pressure. Store the can of VERDESO Foam at room temperature, 68 to 77F (20 to 25C).. Do not place the can of VERDESO Foam in the refrigerator or freezer.. Do not expose containers to heat, and/or store at temperatures above 120F (49C).. Do not break through (puncture) the can of VERDESO Foam.. VERDESO Foam is flammable. Avoid fire, flame, or smoking during and immediately following application.. Keep VERDESO Foam and all medicines out of the reach of children.

SPL UNCLASSIFIED SECTION.

5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression. VERDESO Foam has been shown to reversibly suppress the HPA axis.Topical application of VERDESO Foam may result in systemic absorption and effects including HPA axis suppression, manifestations of Cushings syndrome, hyperglycemia, facial swelling, glycosuria, withdrawal, and growth retardation in children. Use of VERDESO Foam for longer than weeks may suppress the immune system [see Nonclinical Toxicology (13.1)]. Conditions that augment systemic absorption include the application of topical corticosteroids over large body surface areas, prolonged use, or the addition of occlusive dressings. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.The effect of VERDESO Foam on HPA axis function was investigated in pediatric subjects in one trial. In this trial, subjects with atopic dermatitis covering at least 25% of their body applied VERDESO Foam twice daily for weeks. Three out of 75 subjects (4%) displayed adrenal suppression after weeks of use based on the cosyntropin stimulation test. The laboratory suppression was transient; all subjects had returned to normal when tested weeks post-treatment.Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of VERDESO Foam due to their larger skin surface-to-body mass ratios. [see Use in Specific Populations (8.4)]. Concomitant therapy with topical corticosteroids should be used with caution because cumulative effect may occur.

STORAGE AND HANDLING SECTION.

16.2 Storage and Handling. Store at USP controlled room temperature 68F to 77F (20C to 25C) with excursions permitted between 15C (59F) and 30C (86F). WARNING: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose containers to heat, and/or store at temperatures above 120F (49C). Avoid contact with eyes or other mucous membranes.Keep out of reach of children.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk SummaryThere are no available data on VERDESO Foam use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, topical administration of desonide cream, 0.05% formulation during organogenesis caused malformations characteristic of corticosteroids in rats and in rabbits (see Data). The available data do not allow the calculation of relevant comparisons between the systemic exposure of desonide observed in animal studies to the systemic exposure that would be expected in humans after topical use of VERDESO Foam.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.DataAnimal DataTopical administration of desonide cream, 0.05% formulation to pregnant rats (gestational days to 15) and pregnant rabbits (gestational days to 18) at 0.2, 0.6, and 2.0 cream/kg/day was associated with maternal body weight loss at all dose levels in both species. Malformations characteristic of corticosteroids were observed in rats at topical doses of >=0.6 cream/kg/day and in rabbits at topical dose of 2.0 cream/kg/day. No malformations were observed at topical dose of 0.2 cream/kg/day in rats and at topical dose of 0.6 cream/kg/day in rabbits. 8.2 Lactation. Risk SummaryThere are no data on the presence of desonide in human or animal milk, its effects on the breastfed infant, or its effects on milk production.It is not known whether topical administration of VERDESO Foam could result in sufficient systemic absorption to produce detectable quantities in human milk. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for VERDESO Foam and any potential adverse effects on the breastfed infant from VERDESO Foam or from the underlying maternal condition.Clinical ConsiderationsTo minimize potential exposure to the breastfed infant via breast milk, use VERDESO Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women to wash off any VERDESO Foam that has been applied to the nipple and areola prior to breastfeeding to avoid direct infant exposure.. 8.4 Pediatric Use. Safety and efficacy in pediatric patients younger than months have not been established; therefore, the use of VERDESO Foam is not recommended.Because of higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of HPA axis suppression and Cushings syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriateuse of topical corticosteroids in infants and children. HPA axis suppression, Cushings syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroidsto children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.The effect of VERDESO Foam on HPA axis function was investigated in pediatric subjects, aged months to 17 years in one trial. In this trial, subjects with atopic dermatitis covering at least 25% of their body applied VERDESO Foam twice daily for weeks. Three out of 75 subjects (4%) displayed adrenal suppression after weeks of use based on the ACTH stimulation test. The suppression was transient; all subjects cortisol levels had returned to normal when tested weeks post-treatment.. 8.5 Geriatric Use. Clinical trials of VERDESO Foam did not include any subjects aged 65 or over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. VERDESO Foam has been shown to produce reversible HPA axis suppression. (5.1, 8.4, 14)Systemic effects of topical corticosteroids may also include manifestations of Cushings syndrome, hyperglycemia, facial swelling, glycosuria, withdrawal syndrome, and growth retardation in children. (5.1)Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. (5.1, 5.5)Modify use should HPA axis suppression develop. (5.1)Potent corticosteroids, use on large areas, prolonged use, or occlusive use may increase systemic absorption. (5.1)Pediatric patients may be more susceptible to systemic toxicity. (5.1, 8.4, 12.2)Concomitant therapy with topical corticosteroids should be used with caution because cumulative effect may occur. (5.1)Discontinue use if irritation develops. (5.2)Topical corticosteroids may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. (5.3)Initiate appropriate therapy if concomitant skin infections develop. (5.4)The propellant in VERDESO Foam is flammable. Avoid fire, flame, or smoking during and immediately following application. (5.5). VERDESO Foam has been shown to produce reversible HPA axis suppression. (5.1, 8.4, 14). Systemic effects of topical corticosteroids may also include manifestations of Cushings syndrome, hyperglycemia, facial swelling, glycosuria, withdrawal syndrome, and growth retardation in children. (5.1). Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. (5.1, 5.5). Modify use should HPA axis suppression develop. (5.1). Potent corticosteroids, use on large areas, prolonged use, or occlusive use may increase systemic absorption. (5.1). Pediatric patients may be more susceptible to systemic toxicity. (5.1, 8.4, 12.2). Concomitant therapy with topical corticosteroids should be used with caution because cumulative effect may occur. (5.1). Discontinue use if irritation develops. (5.2). Topical corticosteroids may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. (5.3). Initiate appropriate therapy if concomitant skin infections develop. (5.4). The propellant in VERDESO Foam is flammable. Avoid fire, flame, or smoking during and immediately following application. (5.5). 5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression. VERDESO Foam has been shown to reversibly suppress the HPA axis.Topical application of VERDESO Foam may result in systemic absorption and effects including HPA axis suppression, manifestations of Cushings syndrome, hyperglycemia, facial swelling, glycosuria, withdrawal, and growth retardation in children. Use of VERDESO Foam for longer than weeks may suppress the immune system [see Nonclinical Toxicology (13.1)]. Conditions that augment systemic absorption include the application of topical corticosteroids over large body surface areas, prolonged use, or the addition of occlusive dressings. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.An adrenocorticotropic hormone (ACTH) stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.The effect of VERDESO Foam on HPA axis function was investigated in pediatric subjects in one trial. In this trial, subjects with atopic dermatitis covering at least 25% of their body applied VERDESO Foam twice daily for weeks. Three out of 75 subjects (4%) displayed adrenal suppression after weeks of use based on the cosyntropin stimulation test. The laboratory suppression was transient; all subjects had returned to normal when tested weeks post-treatment.Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of VERDESO Foam due to their larger skin surface-to-body mass ratios. [see Use in Specific Populations (8.4)]. Concomitant therapy with topical corticosteroids should be used with caution because cumulative effect may occur.. 5.2 Skin Irritation. VERDESO Foam may cause local skin adverse reactions [see Adverse Reactions (6)]. If irritation develops, VERDESO Foam should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noticing clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing.. 5.3 Ophthalmic Adverse Reactions. Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported in postmarketing experience with the use of topical corticosteroid products [see Adverse Reactions (6.2)].Avoid contact of VERDESO Foam with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.. 5.4 Concomitant Skin Infections. If concomitant skin infections are present or develop, the use of an appropriate antifungal, antibacterial, or antiviral agent should be instituted. If favorable response does not occur promptly, use of VERDESO Foam should be discontinued until the infection has been adequately controlled.. 5.5 Flammable Contents. The contents of VERDESO Foam include alcohol and propane/butane, which are flammable. Avoid fire, flame, and/or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120F (49C).