Metronidazole gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.

For topical use only, not for oral, ophthalmic, or intravaginal use.

Cleanse treated areas before the application of metronidazole gel.

Apply and rub in a thin film of metronidazole gel once daily to affected area(s).

Cosmetics may be applied after the application of metronidazole gel.

Gel, 1%. Metronidazole gel USP is a clear, colorless to pale yellow aqueous gel. Each gram of metronidazole gel USP contains 10 mg (1%) of metronidazole.

Metronidazole gel is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation.

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

Metronidazole gel USP contains metronidazole, USP. It is intended for topical use. Chemically, metronidazole is 2-methyl-5-nitro-1 H-imidazole-1-ethanol. The molecular formula for metronidazole is C 6H 9N 3O 3. It has the following structural formula:

Metronidazole has a molecular weight of 171.2. It is a white to pale yellow crystalline powder. It is slightly soluble in water, acetone, alcohol and methylene chloride. Metronidazole belongs to the nitroimidazole class of compounds.

Metronidazole gel USP is a clear, colorless to pale yellow, aqueous gel; each gram contains 10 mg of metronidazole in a base of betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water.

In a randomized, vehicle-controlled trial, 746 subjects with rosacea were treated with metronidazole gel or vehicle once daily for 10 weeks. Most subjects had a disease severity score of 3 (“moderate”) on the 5-point Investigator Global Assessment (IGA) scale, with 8 to 50 inflammatory lesions and no more than two nodules at baseline. The co-primary efficacy endpoints were the percent reduction in inflammatory lesion counts and percentage of subjects with success on IGA, defined as an IGA score of 0 (“clear”) or 1 (“almost clear”) at Week 10.

The efficacy results are shown in the following table:

Subjects treated with metronidazole gel experienced a mean reduction of 9.4 inflammatory lesions in the Week-10 LOCF group, compared to a reduction of 5.6 for those treated with vehicle, or a difference in means of 3.8 lesions.

The contribution to efficacy of individual components of the vehicle has not been established.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Administration Instructions
Use as directed. Avoid contact with the eyes.
Cleanse treated areas before the application of metronidazole gel.
Advise patients to report any adverse reaction to their healthcare providers.

Lactation
Advise women not to breastfeed during treatment with metronidazole gel [see Use in Specific Populations ( 8.2)] .

Rx Only

Distributed by:
Cosette Pharmaceuticals, Inc.
South Plainfield, NJ 07080

8-0574CPLNC2
VC7695

Metronidazole (met" roe nid' a zole)
Gel

Important: Metronidazole gel is for use on the skin only (topical use). Do not use metronidazole gel in your mouth, eyes, or vagina.

What is metronidazole gel?
Metronidazole gel is a prescription medicine used on the skin (topical) to treat pimples and bumps (inflammatory lesions) caused by a condition called rosacea.
It is not known if metronidazole gel is safe and effective in children.

Do not use metronidazole gel if you are allergic to metronidazole or any of the ingredients in metronidazole gel. See the end of this leaflet for a complete list of ingredients in metronidazole gel.

Before using metronidazole gel, tell your healthcare provider about all your medical conditions, including if you:

• have tingling or numbness in your hands or feet
• have or have had a blood disorder or disease
• are pregnant or plan to become pregnant. It is not known if metronidazole gel will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if metronidazole passes into your breast milk. Do not breastfeed during treatment with metronidazole gel. Talk to your healthcare provider about the best way to feed your baby during treatment with metronidazole gel.

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 a list of them to show your healthcare provider and pharmacist when you get a new medicine

How should I use metronidazole gel?

• Use metronidazole gel exactly as your healthcare provider tells you to.
• Cleanse the treated area before applying metronidazole gel.
• Apply and rub in a thin film of metronidazole gel 1 time a day to the affected area(s).
• You can apply cosmetics after applying metronidazole gel.
• Avoid contact of metronidazole gel with your eyes.

What are the possible side effects of metronidazole gel?
Metronidazole gel 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 metronidazole gel.
• 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 metronidazole gel.
• 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 metronidazole gel.

The most common side effects of metronidazole gel include:

• sore throat and nasal congestion
• upper respiratory tract infections
• headache

Tell your healthcare provider if you get any side effects during treatment with metronidazole gel.

These are not all of the possible side effects of metronidazole gel.
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 Cosette Pharmaceuticals, Inc. at 1-800-922-1038.

How should I store metronidazole gel?

• Store metronidazole gel at room temperature between 68°F to 77°F (20°C to 25°C).

Keep metronidazole gel and all medicines out of the reach of children.

General information about the safe and effective use of metronidazole gel.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use metronidazole gel for a condition for which it was not prescribed. Do not give metronidazole gel 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 metronidazole gel that is written for health professionals.

What are the ingredients in metronidazole gel?
Active ingredient: metronidazole
Inactive ingredients: betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water

Distributed by:
Cosette Pharmaceuticals, Inc.
South Plainfield, NJ 07080

8-0574CPLNC2    VC7695

This Patient Information has been approved by the U.S. Food and Drug Administration

Revised: 10/2022

NDC 0713- 0574-60

Rx only

Metronidazole Gel, USP 1%

For Topical Use Only.

Net Wt. 60 g

Cosette Pharmaceuticals, Inc.

NDC 0713- 0574-60

Rx only

Metronidazole Gel, USP 1%

For Topical Use Only.

Net Wt. 60 g

Cosette Pharmaceuticals, Inc.