ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. Most common adverse reactions (incidence 2%) are nasopharyngitis, upper respiratory tract infection, and headache. 6)To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137, 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 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 practice.In controlled clinical trial, 557 patients used metronidazole gel, 1% and 189 patients used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occurred at rate of >=1%:Table 1: Adverse Reactions That Occurred at Rate of >=1%System Organ Class/Preferred TermMetronidazole Gel, 1%Gel VehicleN= 557N= 189Patients with at least one AE Number (%) of Patients186 (33.4)51 (27.0)Infections and infestations76 (13.6)28 (14.8) Bronchitis6 (1.1)3 (1.6) Influenza8 (1.4)1 (0.5) Nasopharyngitis17 (3.1)8 (4.2) Sinusitis8 (1.4)3 (1.6) Upper respiratory tract infection14 (2.5)4 (2.1) Urinary tract infection6 (1.1)1 (0.5) Vaginal mycosis1 (0.2)2 (1.1)Musculoskeletal and connective tissue disorders19 (3.4)5 (2.6) Back pain3 (0.5)2 (1.1)Neoplasms4 (0.7)2 (1.1) Basal cell carcinoma1 (0.2)2 (1.1)Nervous system disorders18 (3.2)3 (1.6) Headache12 (2.2)1 (0.5)Respiratory, thoracic and mediastinal disorders22 (3.9)5 (2.6) Nasal congestion6 (1.1)3 (1.6)Skin and subcutaneous tissue disorders36 (6.5)12 (6.3) Contact dermatitis7 (1.3)1 (0.5) Dry skin6 (1.1)3 (1.6)Vascular disorders8 (1.4)1 (0.5) Hypertension6 (1.1)1 (0.5)Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than BaselineMetronidazole Gel, 1%Gel VehicleSign/SymptomN= 544N= 184Dryness138 (25.4)63 (34.2) Mild93 (17.1)41 (22.3) Moderate42 (7.7)20 (10.9) Severe3 (0.6)2 (1.1)Scaling134 (24.6)60 (32.6) Mild88 (16.2)32 (17.4) Moderate43 (7.9)27 (14.7) Severe3 (0.6)1 (0.5)Pruritus86 (15.8)35 (19.0) Mild53 (9.7)21 (11.4) Moderate27 (5.0)13 (7.1) Severe6 (1.1)1 (0.5)Stinging/burning56 (10.3)28 (15.2) Mild39 (7.2)18 (9.8) Moderate7 (1.3)9 (4.9) Severe10 (1.8)1 (0.5)The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness of extremities, and nausea. 6.2 Post Marketing Experience. The following adverse reaction has been identified during post approval use of topical metronidazole: peripheral neuropathy. Because this reaction is reported voluntarily from population of uncertain size, it is not always possible to reliably estimate the frequency or establish causal relationship to drug exposure.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. Metronidazole has shown evidence of carcinogenic activity in number of studies involving chronic, oral administration in mice and rats, but not in studies involving hamsters. In several long-term studies in mice, oral doses of approximately 225 mg/m2/day or greater (approximately 37 times the human topical dose on mg/m2 basis) were associated with an increase in pulmonary tumors and lymphomas. Several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m2/day (144 times the human dose). Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohns disease who were treated with 200 to 1200 mg/day of metronidazole for to 24 months. However, in another study, no increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohns disease treated with the drug for months. In one published study, using albino hairless mice, intraperitoneal administration of metronidazole at dose of 45 mg/m2/day (approximately times the human topical dose on mg/m2/day basis) was associated with an increase in ultraviolet radiation-induced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with METROGEL or any marketed metronidazole formulations.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. 12.1 Mechanism of Action. The mechanism of action of metronidazole in the treatment of rosacea is unknown.. 12.2 Pharmacodynamics. The pharmacodynamics of metronidazole in association with the treatment of rosacea are unknown.. 12.3 Pharmacokinetics. Topical administration of one gram dose of METROGEL to the face of 13 patients with moderate to severe rosacea once daily for days resulted in mean +- SD Cmax of metronidazole of 32 +- ng/mL. The mean +- SD AUC(0-24) was 595 +- 154 nghr/mL. The mean Cmax and AUC(0-24) are less than 1% of the value reported for single 250 mg oral dose of metronidazole. The time to maximum plasma concentration (Tmax) was 6-10 hours after topical application.

CLINICAL STUDIES SECTION.

14 CLINICAL STUDIES. In randomized, vehicle-controlled trial, 746 subjects with rosacea were treated with metronidazole gel, 1% or gel vehicle once daily for 10 weeks. Most subjects had moderate rosacea at baseline. Efficacy was determined by recording reduction in inflammatory lesion counts and success rate in the Investigator Global Assessment (percentage of subjects clear and almost clear of rosacea at the end of the study). The scale is based on the following definitions: Table 3: Investigator Global Assessment ScaleScoreGradeDefinition0ClearNo signs or symptoms present; at most, mild erythema1Almost ClearVery mild erythema present. Very few small papules/pustules2MildMild erythema. Several small papules/pustules3ModerateModerate erythema. Several small or large papules/pustules, and up to nodules4SevereSevere erythema. Numerous small and/or large papules/pustules, up to several nodulesThe results are shown in the following table: Table 4: Inflammatory Lesion Counts and Global Scores in Clinical Trial of Rosacea Metronidazole Gel, 1%VehicleNResults (%)NResults (%)Inflammatory lesions557 189 Baseline, mean count 18.3 18.4Week-10, mean count 8.9 12.8Reduction 9.4 (50.7) 5.6 (32.6)Investigator Global Assessment557 189 Subject clear or almost clear 214 (38.42) 52 (27.51)Subject with no change 159 (28.5) 77 (40.7)Subjects treated with metronidazole gel, 1% experienced mean reduction of 9.4 inflammatory lesions in the Week-10 LOCF group, compared to reduction of 5.6 for those treated with vehicle, or difference in means of 3.8 lesions. The contribution to efficacy of individual components of the vehicle has not been established.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. METROGEL is contraindicated in patients with history of hypersensitivity to metronidazole or to any other ingredient in the formulation.. METROGEL is contraindicated in those patients with history of hypersensitivity to metronidazole or to any other ingredient in this formulation. 4).

DESCRIPTION SECTION.

11 DESCRIPTION. METROGEL (metronidazole) Gel, 1% contains metronidazole, USP. Chemically, metronidazole is 2-methyl-5-nitro-1 H-imidazole-1-ethanol. The molecular formula for metronidazole is C6H9N3O3. It has the following structural formula:Metronidazole has molecular weight of 171.16. It is white to pale yellow crystalline powder. It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20C. Metronidazole belongs to the nitroimidazole class of compounds. METROGEL is clear, colorless to pale yellow, aqueous gel; each gram contains 10 mg of metronidazole in base of betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water.. Structural Formula.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. Apply and rub in thin film of METROGEL once daily to affected area(s).A gentle cleanser should be used before the application of METROGEL.Cosmetics may be applied after the application of METROGEL.Not for oral, ophthalmic or intravaginal use.. Not for oral, ophthalmic or intravaginal use. (2)Apply and rub in thin film of METROGEL once daily to affected area(s). (2)Treated areas should be cleansed before the application of METROGEL. (2)Cosmetics may be applied after the application of METROGEL. (2). Not for oral, ophthalmic or intravaginal use. (2). Apply and rub in thin film of METROGEL once daily to affected area(s). (2). Treated areas should be cleansed before the application of METROGEL. (2). Cosmetics may be applied after the application of METROGEL. (2).

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. Gel, 1%. METROGEL is clear, colorless to pale yellow gel. Each gram of METROGEL contains 10mg (1%) of metronidazole. Gel, 1%.

DRUG INTERACTIONS SECTION.

7 DRUG INTERACTIONS. Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in prolongation of prothrombin time. Drug interactions should be kept in mind when METROGEL is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption.. Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in prolongation of prothrombin time. Drug interactions should be kept in mind when METROGEL is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption. (7).

GERIATRIC USE SECTION.

8.5 Geriatric Use. Sixty-six subjects aged 65 years and older were treated with metronidazole gel, 1% in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING. METROGEL(R) clear, colorless to pale yellow in color, and is supplied as follows: 60 gram tube NDC 0299-3820-6055 gram pump NDC 0299-3820-01 Storage Conditions: Store at controlled room temperature: 20 to 25C (68 to 77F), excursions permitted between 15 and 30C (59 and 86F).

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE AND USAGE. METROGEL(R) is indicated for the topical treatment of inflammatory lesions of rosacea. METROGEL(R) (metronidazole) Gel, 1% is nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea.

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION. Patients using METROGEL should receive the following information and instructions.:This medication is to used as directed.It is for external use only.Avoid contact with the eyes.Cleanse affected area(s) before applying METROGEL.This medication should not be used for any condition other than that for which it is prescribed.Keep out of reach of children.Patients should report any adverse reaction to their physicians.Rx Only US Patent No. 6,881,726 and 7,348,317Manufactured by: Production Inc.Baie DUrfe, QC, H8X 3S4 CanadaMade in Canada. Marketed by: Galderma Laboratories, L.P.Fort Worth, TX 76177 USAP50742-3 This medication is to used as directed.. It is for external use only.. Avoid contact with the eyes.. Cleanse affected area(s) before applying METROGEL.. This medication should not be used for any condition other than that for which it is prescribed.. Keep out of reach of children.. Patients should report any adverse reaction to their physicians.

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. The mechanism of action of metronidazole in the treatment of rosacea is unknown.

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. Metronidazole has shown evidence of carcinogenic activity in number of studies involving chronic, oral administration in mice and rats, but not in studies involving hamsters. In several long-term studies in mice, oral doses of approximately 225 mg/m2/day or greater (approximately 37 times the human topical dose on mg/m2 basis) were associated with an increase in pulmonary tumors and lymphomas. Several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m2/day (144 times the human dose). Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohns disease who were treated with 200 to 1200 mg/day of metronidazole for to 24 months. However, in another study, no increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohns disease treated with the drug for months. In one published study, using albino hairless mice, intraperitoneal administration of metronidazole at dose of 45 mg/m2/day (approximately times the human topical dose on mg/m2/day basis) was associated with an increase in ultraviolet radiation-induced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with METROGEL or any marketed metronidazole formulations.

NURSING MOTHERS SECTION.

8.3 Nursing Mothers. After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels taken after topical metronidazole application are significantly lower than those achieved after oral metronidazole decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother and the risk to the infant.

OVERDOSAGE SECTION.

10 OVERDOSAGE. There are no reported human experiences with overdosage of METROGEL. Topically applied metronidazole can be absorbed in sufficient amount to produce systemic effects.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL 60g Tube. metrogel 1%(metronidazole) Gel 1%For topical use onlyNDC 0299-3820-60 Rx Only NET WT. 60 For topical use only. Not for oral, ophthalmic or intravaginal use. Store at controlled room temperature, 68 to 77F (20 25C), excursions permitted between 59 to 86F (15 30C).Keep out of reach of children. Usual dosage: Apply thin film once day to the affected areas. See package insert for complete prescribing instructions. Each gram contains: 10 mg (1%) metronidazole as active ingredient in gel base consisting of betadex, edetate disodium, hydroxyethl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparben, and purified water. Marketed by:GALDERMA LABORATORIES, L.P.Fort Worth, TX 76177 USAAll trademarks are the property of their respective owners.Made in Canada. P50741-6.

PEDIATRIC USE SECTION.

8.4 Pediatric Use. Safety and effectiveness in pediatric patients have not been established.

PHARMACODYNAMICS SECTION.

12.2 Pharmacodynamics. The pharmacodynamics of metronidazole in association with the treatment of rosacea are unknown.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics. Topical administration of one gram dose of METROGEL to the face of 13 patients with moderate to severe rosacea once daily for days resulted in mean +- SD Cmax of metronidazole of 32 +- ng/mL. The mean +- SD AUC(0-24) was 595 +- 154 nghr/mL. The mean Cmax and AUC(0-24) are less than 1% of the value reported for single 250 mg oral dose of metronidazole. The time to maximum plasma concentration (Tmax) was 6-10 hours after topical application.

PREGNANCY SECTION.

8.1 Pregnancy. Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the use of METROGEL in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, METROGEL should be used during pregnancy only if clearly needed.

SPL UNCLASSIFIED SECTION.

5.1 Neurologic Disease. Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Although not evident in clinical trials for topical metronidazole, peripheral neuropathy has been reported with the post approval use. The appearance of abnormal neurologic signs should prompt immediate reevaluation of METROGEL therapy. Metronidazole should be administered with caution to patients with central nervous system diseases.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Teratogenic Effects: Pregnancy Category B. There are no adequate and well-controlled studies with the use of METROGEL in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole in rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, METROGEL should be used during pregnancy only if clearly needed.. 8.3 Nursing Mothers. After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels taken after topical metronidazole application are significantly lower than those achieved after oral metronidazole decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother and the risk to the infant.. 8.4 Pediatric Use. Safety and effectiveness in pediatric patients have not been established.. 8.5 Geriatric Use. Sixty-six subjects aged 65 years and older were treated with metronidazole gel, 1% in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Although not evident in clinical trials for topical metronidazole,peripheral neuropathy has been reported with the post approval use. Theappearance of abnormal neurologic signs should prompt immediatereevaluation of METROGEL therapy. 5.1)Metronidazole is nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. 5.2)If dermatitis occurs, patients may need to discontinue use. 5.3)Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. 5.4). Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Although not evident in clinical trials for topical metronidazole,peripheral neuropathy has been reported with the post approval use. Theappearance of abnormal neurologic signs should prompt immediatereevaluation of METROGEL therapy. 5.1). Metronidazole is nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. 5.2). If dermatitis occurs, patients may need to discontinue use. 5.3). Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. 5.4). 5.1 Neurologic Disease. Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Although not evident in clinical trials for topical metronidazole, peripheral neuropathy has been reported with the post approval use. The appearance of abnormal neurologic signs should prompt immediate reevaluation of METROGEL therapy. Metronidazole should be administered with caution to patients with central nervous system diseases.. 5.2 Blood Dyscrasias. Metronidazole is nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia.. 5.3 Contact Dermatitis. Irritant and allergic contact dermatitis have been reported. If dermatitis occurs, patients may need to discontinue use.. 5.4 Eye Irritation. Topical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes.

LABOR & DELIVERY SECTION.

8.2 Lactation. Risk SummaryIt is not known whether metronidazole is present in human milk after topical administration. Published literature reports the presence of metronidazole in human milk after oral administration. There are reports of diarrhea and candida infection in breastfed infants of mothers receiving oral treatment with metronidazole. There are no data on the effects of metronidazole on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with METROGEL.

PATIENT MEDICATION INFORMATION SECTION.

PATIENT INFORMATION METROGEL(R) (MET-TRO-GEL) (metronidazole) GelImportant: METROGEL is for use on the skin only (topical use). Do not use METROGEL in your mouth, eyes, or vagina.What is METROGELMETROGEL is prescription medicine used on the skin (topical) to treat pimples and bumps (inflammatory lesions) caused by condition called rosacea. It is not known if METROGEL is safe and effective in children.Do not use METROGEL if you are allergic to metronidazole or any of the ingredients in METROGEL. See the end of this leaflet for complete list of ingredients in METROGEL.Before using METROGEL, tell your healthcare provider about all your medical conditions, including if you:have tingling or numbness in your hands or feethave or have had blood disorder or diseaseare pregnant or plan to become pregnant. It is not known if METROGEL will harm your unborn babyare breastfeeding or plan to breastfeed. It is not known if METROGEL passes into your breast milk. Do not breastfeed during treatment with METROGEL. Talk to your healthcare provider about the best way to feed your baby during treatment with METROGEL.Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep list of them to show your healthcare provider and pharmacist when you get new medicine.How should use METROGELUse METROGEL exactly as your healthcare provider tells you to.Cleanse the treated area before applying METROGEL.Apply and rub in thin film of METROGEL time day to the affected area(s).You can apply cosmetics after applying METROGEL. Avoid contact of METROGEL with your eyes.What are the possible side effects of METROGEL METROGEL may cause serious side effects, including:Peripheral neuropathy. Tingling, burning, pain or numbness in the hands or feet (peripheral neuropathy) have happened in people treated with metronidazole used on the skin. Tell your healthcare provider if you experience tingling, burning, pain or numbness in your hands or feet during treatment with METROGEL.Skin reactions, including allergic reactions. Tell your healthcare provider if you develop any skin reactions, including rash, itching, redness, swelling, or blisters during treatment with METROGEL. Eye irritation. Tearing from eye irritation has happened in people treated with metronidazole used on the skin. Tell your healthcare provider if you experience tearing, redness or discomfort of the eyes during treatment with METROGEL.The most common side effects of METROGEL include:sore throat and nasal congestionupper respiratory tract infectionsheadacheTell your healthcare provider if you get any side effects during treatment with METROGEL.These are not all of the possible side effects of METROGEL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137.How should store METROGELStore METROGEL at room temperature between 68F to 77F (20C to 25C). Keep METROGEL and all medicines out of the reach of children.General information about the safe and effective use of METROGEL. Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. Do not use METROGEL for condition for which it was not prescribed. Do not give METROGEL to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about METROGEL that is written for health professionals.What are the ingredients in METROGEL Active ingredient: metronidazole Inactive ingredients: betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water Marketed by: Galderma Laboratories, L.P., Fort Worth, Texas 76177 USAP50742-4Made in Canada US Patent No. 6,881,726 and 7,348,317 For more information, call 1-866-735-4137. This Patient Information has been approved by the U.S. Food and Drug Administration.Issued: 03/2022. have tingling or numbness in your hands or feet. have or have had blood disorder or disease. are pregnant or plan to become pregnant. It is not known if METROGEL will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if METROGEL passes into your breast milk. Do not breastfeed during treatment with METROGEL. Talk to your healthcare provider about the best way to feed your baby during treatment with METROGEL.. Use METROGEL exactly as your healthcare provider tells you to.. Cleanse the treated area before applying METROGEL.. Apply and rub in thin film of METROGEL time day to the affected area(s).. You can apply cosmetics after applying METROGEL. Avoid contact of METROGEL with your eyes.. Peripheral neuropathy. Tingling, burning, pain or numbness in the hands or feet (peripheral neuropathy) have happened in people treated with metronidazole used on the skin. Tell your healthcare provider if you experience tingling, burning, pain or numbness in your hands or feet during treatment with METROGEL.. Skin reactions, including allergic reactions. Tell your healthcare provider if you develop any skin reactions, including rash, itching, redness, swelling, or blisters during treatment with METROGEL. Eye irritation. Tearing from eye irritation has happened in people treated with metronidazole used on the skin. Tell your healthcare provider if you experience tearing, redness or discomfort of the eyes during treatment with METROGEL.. sore throat and nasal congestion. upper respiratory tract infections. headache. Store METROGEL at room temperature between 68F to 77F (20C to 25C).