LACTATION SECTION.

8.2 Lactation Risk Summary. There is no available information on the presence of miconazole in human milk, or the effects on the breastfed child, or the effects on milk production following use of miconazole nitrate, zinc oxide and white petrolatum ointment.The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for miconazole nitrate, zinc oxide and white petrolatum ointment and any potential adverse effects on the breastfed infant from miconazole nitrate, zinc oxide and white petrolatum ointment or from the underlying maternal condition.

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action The miconazole component of miconazole nitrate, zinc oxide and white petrolatum ointment is an antifungal agent [see Clinical Pharmacology (12.4)]. The mechanism of action of white petrolatum and zinc oxide for the adjunctive treatment of diaper dermatitis is unknown.

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of miconazole nitrate, zinc oxide and white petrolatum ointment in animals has not been evaluated.Miconazole nitrate was negative in bacterial reverse mutation test, chromosome aberration test in mice, and micronucleus assays in mice and rats.Miconazole nitrate had no adverse effect on fertility in study in rats at oral doses of up to 320 mg/kg/day.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 0.25%, 15% and 81.35% NDC 0378-8222-50MiconazoleNitrate,0.25%Zinc Oxide,15%and WhitePetrolatum,81.35% OintmentFor Topical Use OnlyUsual Dosage: See package insert.Caution: Not for oral, ophthalmic, orintravaginal use. Keep out of reach ofchildren. If seal is damaged orpunctured, do not use, and returnproduct to place of purchase.Description: Each gram contains 2.5 mgmiconazole nitrate USP, 150 mg zincoxide USP, and 813.5 mg whitepetrolatum USP containing butylatedhydroxytoluene, trihyforxystearin, andChemoderm 1001/B fragrance.Store at 20o to 25oC (68o to 77oF).[See USP Controlled RoomTemperature.]See flap for lot number and expiration date.For additional information, call Mylan at1-877-446-3679 (1-877-4-INFO-RX).Serious side effects associated with theuse of this product may be reported tothis number.Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.Made in CanadaCON:8222:50:1C:R1 301922-01Mylan.com. Miconazole Nitrate 0.25%, Zinc Oxide 15%, and White Petrolatum 81.35% Carton Label.

PEDIATRIC USE SECTION.

8.4 Pediatric Use Efficacy was not demonstrated in infants less than weeks of age. Safety and efficacy have not been established in very-low-birth-weight infants (less than 1500 g).Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent diaper dermatitis.The safety of miconazole nitrate, zinc oxide and white petrolatum ointment when used for longer than days is not known. Do not use more than days.

PHARMACODYNAMICS SECTION.

12.2 Pharmacodynamics The human pharmacodynamics of miconazole nitrate, zinc oxide and white petrolatum ointment is unknown [see Clinical Pharmacology (12.4) for fungal pharmacodynamics].

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rate 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.A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the miconazole nitrate, zinc oxide and white petrolatum ointment group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at rate of >= 1% for subjects who were treated with miconazole nitrate, zinc oxide and white petrolatum ointment were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.. 6.2 Post-marketing Experience The following adverse reactions have been identified during post approval use of miconazole nitrate, zinc oxide and white petrolatum ointment. 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.Gastrointestinal Disorders: vomitingGeneral Disorders and Administration Site Conditions: burning sensation, condition aggravated, inflammation, painInjury, Poisoning and Procedural Complications: accidental exposureSkin and Subcutaneous Tissue Disorders: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of miconazole nitrate, zinc oxide and white petrolatum ointment in animals has not been evaluated.Miconazole nitrate was negative in bacterial reverse mutation test, chromosome aberration test in mice, and micronucleus assays in mice and rats.Miconazole nitrate had no adverse effect on fertility in study in rats at oral doses of up to 320 mg/kg/day.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The miconazole component of miconazole nitrate, zinc oxide and white petrolatum ointment is an antifungal agent [see Clinical Pharmacology (12.4)]. The mechanism of action of white petrolatum and zinc oxide for the adjunctive treatment of diaper dermatitis is unknown.. 12.2 Pharmacodynamics The human pharmacodynamics of miconazole nitrate, zinc oxide and white petrolatum ointment is unknown [see Clinical Pharmacology (12.4) for fungal pharmacodynamics].. 12.3 Pharmacokinetics The topical absorption of miconazole from miconazole nitrate, zinc oxide and white petrolatum ointment was studied in immunocompetent male and female infants and children (n 17) with diaper dermatitis complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) ranging in age from month to 21 months. After multiple daily applications to the affected area at every diaper change (approximately 5-12 times per day) for days, the plasma concentrations of miconazole were below the lower limit of quantitation (LOQ) of 0.5 ng/mL in 15 out of 17 (88%) subjects. In the other remaining subjects, the plasma concentrations of miconazole were 0.57 and 0.58 ng/mL, respectively at single timepoint (4 hours after the last application) on Day 7.. 12.4 Microbiology The miconazole nitrate component in this product has been shown to have in vitro activity against Candida albicans, an organism that is associated with diaper dermatitis. The activity of miconazole nitrate against C. albicans is based on the inhibition of the ergosterol biosynthesis in the cell membrane. The accumulation of ergosterol precursors and toxic peroxides results in cytolysis of the cell. In vitro minimal inhibitory concentration (MIC) test results for C. albicans isolates obtained from treatment failures in Clinical Study [see Clinical Studies (14)] does not appear to indicate that resistance to miconazole nitrate was the reason for treatment failure. The clinical significance of the in vitro activity of miconazole nitrate against C. albicans in the setting of diaper dermatitis is unclear.

CLINICAL STUDIES SECTION.

14 CLINICAL STUDIES Study was double-blind, multicenter study in which miconazole nitrate, zinc oxide and white petrolatum ointment was compared to the zinc oxide and white petrolatum combination treatment and included 236 infants and toddlers with diaper dermatitis, complicated by candidiasis as documented by KOH tests that demonstrated pseudohyphae and/or budding yeasts. Study medication was applied at every diaper change for days.The primary endpoint was Overall Cure and required that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically cured (eradication of candidiasis). Primary efficacy was assessed week following the end of treatment, at Day 14.Study results are shown in the following table.Overall Cure at Day 14 Miconazole Nitrate, Zinc Oxide and White Petrolatum Ointmentn 112Zinc Oxide/White Petrolatumn 124 26 (23%) 12 (10%)Two additional studies provided supportive evidence of the clinical efficacy of miconazole nitrate, zinc oxide and white petrolatum ointment in infants and toddlers with diaper dermatitis, some of whom cultured positive for C. albicans. However, candidal infection was not documented in the culture-positive subjects, as microscopic testing (e.g. KOH) was not done. Therefore, the positive culture results may have reflected colonization rather than infection.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS None. oNone. oNone.

DESCRIPTION SECTION.

11 DESCRIPTION Miconazole nitrate, zinc oxide and white petrolatum ointment contains the synthetic antifungal agent, miconazole nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP.The chemical name of miconazole nitrate is 1-[2, 4-dichloro-ss-(2,4-dichlorobenzyl)oxy phenethyl] imidazole mononitrate with empirical formula C18H14Cl4N2OoHNO3 and molecular weight of 479.15. The structural formula of miconazole nitrate is as follows:The zinc oxide has an empirical formula of ZnO and molecular weight of 81.39.The white petrolatum, which is obtained from petroleum and is wholly or nearly decolorized, is purified mixture of semisolid saturated hydrocarbons having the general chemical formula CnH2n+2. The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer.Each gram of miconazole nitrate, zinc oxide and white petrolatum ointment contains 2.5 mg of miconazole nitrate, USP, 150 mg of zinc oxide, USP and 813.5 mg of white petrolatum, USP containing butylated hydroxytoluene, trihydroxystearin, and Chemoderm 1001/B fragrance.Miconazole nitrate, zinc oxide and white petrolatum ointment is smooth, uniform, white ointment.. Miconazole Nitrate Structural Formula.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION Miconazole nitrate, zinc oxide and white petrolatum ointment is not for oral, ophthalmic, or intravaginal use. Before applying miconazole nitrate, zinc oxide and white petrolatum ointment, gently cleanse the skin with lukewarm water and pat dry with soft towel. Avoid using any scented soaps, shampoos, or lotions on the diaper area.Gently apply thin layer of miconazole nitrate, zinc oxide and white petrolatum ointment to the diaper area with each diaper change for days. Do not rub miconazole nitrate, zinc oxide and white petrolatum ointment into the skin as this may cause additional irritation. Thoroughly wash hands after applying miconazole nitrate, zinc oxide and white petrolatum ointment. Continue treatment for the full days, even if there is improvement.Do not use miconazole nitrate, zinc oxide and white petrolatum ointment for longer than days. The safety of miconazole nitrate, zinc oxide and white petrolatum ointment when used for longer than days is not known. If symptoms have not improved by day 7, see your health care provider.. oMiconazole nitrate, zinc oxide and white petrolatum ointment is for topical use only. Miconazole nitrate, zinc oxide and white petrolatum ointment is not for oral, ophthalmic, or intravaginal use. (2) oMiconazole nitrate, zinc oxide and white petrolatum ointment should be applied as thin layer to the affected area at each diaper change for days. (2) oMiconazole nitrate, zinc oxide and white petrolatum ointment should be used as part of treatment regimen that includes gentle cleansing of the diaper area and frequent diaper changes. (2). oMiconazole nitrate, zinc oxide and white petrolatum ointment is for topical use only. Miconazole nitrate, zinc oxide and white petrolatum ointment is not for oral, ophthalmic, or intravaginal use. (2) oMiconazole nitrate, zinc oxide and white petrolatum ointment should be applied as thin layer to the affected area at each diaper change for days. (2) oMiconazole nitrate, zinc oxide and white petrolatum ointment should be used as part of treatment regimen that includes gentle cleansing of the diaper area and frequent diaper changes. (2).

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS Miconazole Nitrate, 0.25%, Zinc Oxide, 15% and White Petrolatum, 81.35% Ointment contains 2.5 mg of miconazole nitrate, USP, 150 mg of zinc oxide, USP and 813.5 mg of white petrolatum, USP per gram.. oOintment with miconazole nitrate USP, 0.25%; zinc oxide USP, 15%; white petrolatum USP, 81.35%. (3). oOintment with miconazole nitrate USP, 0.25%; zinc oxide USP, 15%; white petrolatum USP, 81.35%. (3).

DRUG INTERACTIONS SECTION.

7 DRUG INTERACTIONS Drug-drug interaction studies were not conducted. Women who take warfarin anticoagulant and use miconazole intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR), and bleeding. The potential for this interaction between warfarin and miconazole nitrate, zinc oxide and white petrolatum ointment is unknown.

GERIATRIC USE SECTION.

8.5 Geriatric Use Safety and efficacy in geriatric population have not been evaluated.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Miconazole Nitrate, 0.25%, Zinc Oxide, 15% and White Petrolatum, 81.35% Ointment contains 2.5 mg of miconazole nitrate, USP, 150 mg of zinc oxide, USP and 813.5 mg of white petrolatum, USP per gram. The smooth, uniform, white ointment supplied in an aluminum tube is available as follows:NDC 0378-8222-50carton containing one 50 gram tube. 16.2 Storage Conditions Store at 20 to 25C (68 to 77F). [See USP Controlled Room Temperature.] Keep out of reach of children.

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE oMiconazole nitrate, zinc oxide and white petrolatum ointment is indicated for adjunctive treatment of diaper dermatitis when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) in immunocompetent pediatric patients weeks and older. (1.1) oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used as substitute for frequent diaper changes. (1.1) oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance. (1.2). oMiconazole nitrate, zinc oxide and white petrolatum ointment is indicated for adjunctive treatment of diaper dermatitis when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) in immunocompetent pediatric patients weeks and older. (1.1) oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used as substitute for frequent diaper changes. (1.1) oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance. (1.2). 1.1 Indication Miconazole nitrate, zinc oxide and white petrolatum ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients weeks and older. positive fungal culture for Candida albicans is not adequate evidence of candidal infection since colonization with C. albicans can result in positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.Miconazole nitrate, zinc oxide and white petrolatum ointment should be used as part of treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes. Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used as substitute for frequent diaper changes. 1.2 Limitations of Use The safety and efficacy of miconazole nitrate, zinc oxide and white petrolatum ointment have not been demonstrated in immunocompromised patients, or in infants less than weeks of age (premature or term).The safety and efficacy of miconazole nitrate, zinc oxide and white petrolatum ointment have not been evaluated in incontinent adult patients. Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling Patients using miconazole nitrate, zinc oxide and white petrolatum ointment should be informed about the following information:oMiconazole nitrate, zinc oxide and white petrolatum ointment should be used only as directed by the health care provider. oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used as substitute for frequent diaper changes. oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent diaper dermatitis. oMiconazole nitrate, zinc oxide and white petrolatum ointment is for external use only. It is not for oral, ophthalmic, or intravaginal use. oGently cleanse the diaper area with lukewarm water or very mild soap and pat the area dry with soft towel before applying miconazole nitrate, zinc oxide and white petrolatum ointment. oGently apply miconazole nitrate, zinc oxide and white petrolatum ointment to the diaper area with the fingertips after each diaper change. Do not rub miconazole nitrate, zinc oxide and white petrolatum ointment into the skin as this may cause additional irritation. oThoroughly wash hands after applying miconazole nitrate, zinc oxide and white petrolatum ointment. oTreatment should be continued for days, even if there is improvement. Do not use miconazole nitrate, zinc oxide and white petrolatum ointment for longer than days. If symptoms have not improved by day 7, see your health care provider. oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used on children for whom it is not prescribed.. oMiconazole nitrate, zinc oxide and white petrolatum ointment should be used only as directed by the health care provider. oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used as substitute for frequent diaper changes. oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent diaper dermatitis. oMiconazole nitrate, zinc oxide and white petrolatum ointment is for external use only. It is not for oral, ophthalmic, or intravaginal use. oGently cleanse the diaper area with lukewarm water or very mild soap and pat the area dry with soft towel before applying miconazole nitrate, zinc oxide and white petrolatum ointment. oGently apply miconazole nitrate, zinc oxide and white petrolatum ointment to the diaper area with the fingertips after each diaper change. Do not rub miconazole nitrate, zinc oxide and white petrolatum ointment into the skin as this may cause additional irritation. oThoroughly wash hands after applying miconazole nitrate, zinc oxide and white petrolatum ointment. oTreatment should be continued for days, even if there is improvement. Do not use miconazole nitrate, zinc oxide and white petrolatum ointment for longer than days. If symptoms have not improved by day 7, see your health care provider. oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used on children for whom it is not prescribed.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics The topical absorption of miconazole from miconazole nitrate, zinc oxide and white petrolatum ointment was studied in immunocompetent male and female infants and children (n 17) with diaper dermatitis complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) ranging in age from month to 21 months. After multiple daily applications to the affected area at every diaper change (approximately 5-12 times per day) for days, the plasma concentrations of miconazole were below the lower limit of quantitation (LOQ) of 0.5 ng/mL in 15 out of 17 (88%) subjects. In the other remaining subjects, the plasma concentrations of miconazole were 0.57 and 0.58 ng/mL, respectively at single timepoint (4 hours after the last application) on Day 7.

PREGNANCY SECTION.

8.1 Pregnancy Risk Summary. There are no available data on miconazole nitrate, zinc oxide and white petrolatum ointment use in pregnant women to inform drug-associated risk for adverse developmental outcomes. In animal reproduction studies, prolonged gestation, increased number of resorptions, and decreased numbers of live young were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of miconazole nitrate, zinc oxide and white petrolatum ointment [see Clinical Pharmacology (12.3)]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively. Data. Animal Data Miconazole nitrate administration has been shown to result in prolonged gestation and decreased numbers of live young in rats and in increased number of resorptions and decreased number of live young in rabbits at oral doses of 100 mg/kg/day and 80 mg/kg/day.

RISKS.

Risk Summary. There are no available data on miconazole nitrate, zinc oxide and white petrolatum ointment use in pregnant women to inform drug-associated risk for adverse developmental outcomes. In animal reproduction studies, prolonged gestation, increased number of resorptions, and decreased numbers of live young were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of miconazole nitrate, zinc oxide and white petrolatum ointment [see Clinical Pharmacology (12.3)]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively.

SPL PATIENT PACKAGE INSERT SECTION.

PATIENT INFORMATION Miconazole Nitrate, Zinc Oxide and White Petrolatum OintmentImportant Information:Miconazole nitrate, zinc oxide and white petrolatum ointment is for use on the skin only. Do not use miconazole nitrate, zinc oxide and white petrolatum ointment in the eyes, mouth, or vagina. What is miconazole nitrate, zinc oxide and white petrolatum ointment Miconazole nitrate, zinc oxide and white petrolatum ointment is prescription medicine used on the skin (topical) to treat children weeks of age and older with normal immune system who have diaper rash (dermatitis) and who also have yeast infection (candidiasis). oYour childs healthcare provider should do test to check to make sure that your child also has yeast infection before starting treatment with miconazole nitrate, zinc oxide and white petrolatum ointment. oMiconazole nitrate, zinc oxide and white petrolatum ointment should be used along with gentle cleaning of the diaper area and changing your childs diaper often. See, How should use miconazole nitrate, zinc oxide and white petrolatum ointment for detailed instructions on how to use miconazole nitrate, zinc oxide and white petrolatum ointment the right way. oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent diaper rash from developing (preventative treatment). Using miconazole nitrate, zinc oxide and white petrolatum ointment as preventative treatment may cause miconazole nitrate, zinc oxide and white petrolatum ointment to no longer work (resistance). It is not known if miconazole nitrate, zinc oxide and white petrolatum ointment is safe and effective for use in incontinent adults.It is not known if miconazole nitrate, zinc oxide and white petrolatum ointment is safe and effective for use in children less than weeks of age or very low birth weight (less than 1500 grams).Before using miconazole nitrate, zinc oxide and white petrolatum ointment, tell your childs healthcare provider about all their medical conditions.How should use miconazole nitrate, zinc oxide and white petrolatum ointmentoUse miconazole nitrate, zinc oxide and white petrolatum ointment exactly as your childs healthcare provider tells you to use it.oGently clean the skin on your childs diaper area with warm (not hot) water and pat the area dry with soft towel.oUsing your fingertips, apply thin layer of miconazole nitrate, zinc oxide and white petrolatum ointment to the affected area at each diaper change for days. Do not rub miconazole nitrate, zinc oxide and white petrolatum ointment into your childs skin. Rubbing the skin can cause more irritation. oWash your hands after applying miconazole nitrate, zinc oxide and white petrolatum ointment.oMiconazole nitrate, zinc oxide and white petrolatum ointment should be used for the full days of treatment. Do not stop treatment before the full days, even if the symptoms improve. oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used for longer than days. Call your childs healthcare provider if the diaper rash gets worse or does not go away with days of treatment with miconazole nitrate, zinc oxide and white petrolatum ointment. oCall your childs healthcare provider or poison control center right away if miconazole nitrate, zinc oxide and white petrolatum ointment is swallowed or gets in the eyes.What should avoid while using miconazole nitrate, zinc oxide and white petrolatum ointmentoAvoid using scented soaps, shampoos or lotions in the diaper area during treatment with miconazole nitrate, zinc oxide and white petrolatum ointment.What are the possible side effects of miconazole nitrate, zinc oxide and white petrolatum ointmentMiconazole nitrate, zinc oxide and white petrolatum ointment may cause serious side effects, including:oSkin irritation. Stop using miconazole nitrate, zinc oxide and white petrolatum ointment and call your childs healthcare provider if your childs diaper rash gets worse or if your child develops skin irritation at the application site during treatment with miconazole nitrate, zinc oxide and white petrolatum ointment. These are not all the possible side effects of miconazole nitrate, zinc oxide and white petrolatum ointment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should store miconazole nitrate, zinc oxide and white petrolatum ointmentoStore miconazole nitrate, zinc oxide and white petrolatum ointment at room temperature between 68F to 77F (20C to 25C).oKeep miconazole nitrate, zinc oxide and white petrolatum ointment and all medicines out of the reach of children.General information about the safe and effective use of miconazole nitrate, zinc oxide and white petrolatum ointment.Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. Do not use miconazole nitrate, zinc oxide and white petrolatum ointment for condition for which it was not prescribed. Do not give miconazole nitrate, zinc oxide and white petrolatum ointment to other people, even if they have the same symptoms your child has. It may harm them. You can ask your childs healthcare provider or pharmacist for information about miconazole nitrate, zinc oxide and white petrolatum ointment that is written for healthcare professionals.What are the ingredients in miconazole nitrate, zinc oxide and white petrolatum ointmentActive Ingredients: miconazole nitrate, zinc oxide, and white petrolatum Inactive Ingredients: trihydroxystearin, butylated hydroxytoluene (BHT), and Chemoderm 1001/B fragranceManufactured for: Mylan Pharmaceuticals Inc.,Morgantown, WV 26505 U.S.A.This Patient Information leaflet has been approved by the U.S. Food and Drug Administration. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.Manufactured by: Confab Laboratories, Inc. Saint-Hubert (QC) Canada J3Y 3X3Revised: 8/2018301923-02CON:MZPOING:R2. oYour childs healthcare provider should do test to check to make sure that your child also has yeast infection before starting treatment with miconazole nitrate, zinc oxide and white petrolatum ointment. oMiconazole nitrate, zinc oxide and white petrolatum ointment should be used along with gentle cleaning of the diaper area and changing your childs diaper often. See, How should use miconazole nitrate, zinc oxide and white petrolatum ointment for detailed instructions on how to use miconazole nitrate, zinc oxide and white petrolatum ointment the right way. oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent diaper rash from developing (preventative treatment). Using miconazole nitrate, zinc oxide and white petrolatum ointment as preventative treatment may cause miconazole nitrate, zinc oxide and white petrolatum ointment to no longer work (resistance). oUse miconazole nitrate, zinc oxide and white petrolatum ointment exactly as your childs healthcare provider tells you to use it.. oGently clean the skin on your childs diaper area with warm (not hot) water and pat the area dry with soft towel.. oUsing your fingertips, apply thin layer of miconazole nitrate, zinc oxide and white petrolatum ointment to the affected area at each diaper change for days. Do not rub miconazole nitrate, zinc oxide and white petrolatum ointment into your childs skin. Rubbing the skin can cause more irritation. oWash your hands after applying miconazole nitrate, zinc oxide and white petrolatum ointment.. oMiconazole nitrate, zinc oxide and white petrolatum ointment should be used for the full days of treatment. Do not stop treatment before the full days, even if the symptoms improve. oMiconazole nitrate, zinc oxide and white petrolatum ointment should not be used for longer than days. Call your childs healthcare provider if the diaper rash gets worse or does not go away with days of treatment with miconazole nitrate, zinc oxide and white petrolatum ointment. oCall your childs healthcare provider or poison control center right away if miconazole nitrate, zinc oxide and white petrolatum ointment is swallowed or gets in the eyes.. oAvoid using scented soaps, shampoos or lotions in the diaper area during treatment with miconazole nitrate, zinc oxide and white petrolatum ointment.. oSkin irritation. Stop using miconazole nitrate, zinc oxide and white petrolatum ointment and call your childs healthcare provider if your childs diaper rash gets worse or if your child develops skin irritation at the application site during treatment with miconazole nitrate, zinc oxide and white petrolatum ointment. oStore miconazole nitrate, zinc oxide and white petrolatum ointment at room temperature between 68F to 77F (20C to 25C).. oKeep miconazole nitrate, zinc oxide and white petrolatum ointment and all medicines out of the reach of children.

SPL UNCLASSIFIED SECTION.

1.1 Indication Miconazole nitrate, zinc oxide and white petrolatum ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients weeks and older. positive fungal culture for Candida albicans is not adequate evidence of candidal infection since colonization with C. albicans can result in positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.Miconazole nitrate, zinc oxide and white petrolatum ointment should be used as part of treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes. Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used as substitute for frequent diaper changes.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary. There are no available data on miconazole nitrate, zinc oxide and white petrolatum ointment use in pregnant women to inform drug-associated risk for adverse developmental outcomes. In animal reproduction studies, prolonged gestation, increased number of resorptions, and decreased numbers of live young were observed after oral administration of miconazole nitrate during organogenesis to pregnant rats and rabbits. No comparisons of animal exposure with human exposure may be calculated due to minimal systemic exposure in humans after topical administration of miconazole nitrate, zinc oxide and white petrolatum ointment [see Clinical Pharmacology (12.3)]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is to 4% and 15 to 20%, respectively. Data. Animal Data Miconazole nitrate administration has been shown to result in prolonged gestation and decreased numbers of live young in rats and in increased number of resorptions and decreased number of live young in rabbits at oral doses of 100 mg/kg/day and 80 mg/kg/day.. 8.2 Lactation Risk Summary. There is no available information on the presence of miconazole in human milk, or the effects on the breastfed child, or the effects on milk production following use of miconazole nitrate, zinc oxide and white petrolatum ointment.The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for miconazole nitrate, zinc oxide and white petrolatum ointment and any potential adverse effects on the breastfed infant from miconazole nitrate, zinc oxide and white petrolatum ointment or from the underlying maternal condition.. 8.4 Pediatric Use Efficacy was not demonstrated in infants less than weeks of age. Safety and efficacy have not been established in very-low-birth-weight infants (less than 1500 g).Miconazole nitrate, zinc oxide and white petrolatum ointment should not be used to prevent diaper dermatitis.The safety of miconazole nitrate, zinc oxide and white petrolatum ointment when used for longer than days is not known. Do not use more than days.. 8.5 Geriatric Use Safety and efficacy in geriatric population have not been evaluated.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS . oIf irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. (5.1). oIf irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider. (5.1). 5.1 Skin Irritation If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.