Metronidazole

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

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

Gel, 1%. Metronidazole Gel is a clear, colorless to pale yellow gel. Each gram of Metronidazole Gel 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.

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Neurologic Disease [see Warnings and Precautions (5.1)]
  Contact Dermatitis [see Warnings and Precautions (5.3)] 
• Eye Irritation [see Warnings and Precautions (5.4)]

Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Use caution when prescribing for patients who are receiving anticoagulant treatment.

Metronidazole topical gel, 1% is a nitroimidazole for topical use. Metronidazole Gel is a clear, colorless to pale yellow, aqueous gel. Each gram contains 10 mg of metronidazole. 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:

Structural Formula

Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20˚C. Metronidazole belongs to the nitroimidazole class of compounds.
The inactive ingredients are 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.

How Supplied
Metronidazole Gel is clear, colorless to pale yellow in color, and supplied as follows:
55 gram pump – NDC 68308-663-55
60 gram tube – NDC 68308-663-60

Storage and Handling
Store at controlled room temperature: 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F).

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

Administration Instructions
Use as directed. Avoid contact with the eyes [see Warnings and Precautions (5.4)].
Cleanse treated areas before the application of Metronidazole Gel [see Dosage and Administration (2)]
Advise patients to report any adverse reaction to their healthcare providers.

Neurologic Disease
Advise patients to immediately report any abnormal neurologic signs to their healthcare provider [see Warnings and Precautions (5.1)].

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

Rx Only
US Patent No. 6,881,726 and 7,348,317
Distributed by:
Mayne Pharma
Raleigh, NC 27609 
P58252-0
Product of Canada
All trademarks are the property of their respective owners.

Metronidazole 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 Gel 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 Mayne Pharma at 1-844-825-8500.

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:
Mayne  Pharma
Raleigh, NC 27609
P58252-0
Product of Canada
US Patent No. 6,881,726 and 7,348,317

This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised 10/2024

NDC 68308-663-55

Metronidazole Gel 1%

Pump

For topical use only


Rx Only

NET WT. 55g
maynepharma


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

Store at controlled room temperature, 68° to 77°F (20° - 25°C), excursions permitted between 59° to 86°F (15° - 30°C).
Keep out of reach of children.

Usual dosage: Apply a thin film once a day to the affected areas.  See package insert for complete prescribing instructions.


Each gram contains: 10 mg (1%) metronidazole as active ingredient in a gel base consisting of betadex, edetate disodium, hydroxyethl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparben, and purified water.

Distributed by:
Mayne Pharma
Raleigh, NC 27609
Product of Canada.

P57418-0

NDC 68308-663-60
Metronidazole Gel
1% 
For Topical Use Only

Rx Only
Net Wt. 60 g

maynepharma

Product of Canada
Distributed by:
MaynePharma
Raleigh, NC 27609

P58251-0


FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC OR INTRAVAGINAL USE.
STORE AT CONTROLLED ROOM TEMPERATURE 68º TO 77ºF(20º - 25º C)
EXCURSIONS PERMITTED BETWEEN 59º AND 86ºF (15º - 30ºC)

Usual dosage: Apply a thin film once a day to the affected areas. 
See package insert for complete prescribing instructions.

Each gram contains: Active: 10 mg (1%) metronidazole as active ingredient in a gel base consisting of betadex, edetate disodium, hydroxyethl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparben, and purified water.

See crimp of tube for lot number and expiration date.