Metronidazole 10 mg/g Gel
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nitroimidazole Antimicrobial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Metronidazole topical is used to treat rosacea (a skin disease that causes redness, flushing, and pimples on the face). Metronidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria.
Read the full MedlinePlus article ↗- This is one of the most important things to know about metronidazole. If you drink alcohol — or consume products containing propylene glycol — while taking it, you can have a prett...
- Why do I have to avoid alcohol while taking this?
- Yes, completely normal and actually really important. Trichomoniasis is a sexually transmitted infection, so even if your partner has no symptoms, they can still carry the parasite...
- My partner and I both have to take this for trichomoniasis — is that normal?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Metronidazole — tap one for details:
Metronidazole may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII JV039JZZ3A
Betadex is a modified sugar molecule derived from starch. It acts as a solubilizer and stabilizer in medicines, helping dissolve poorly soluble drugs and keep them stable during storage.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
-
UNII ZYD53NBL45
Hydroxyethyl cellulose is a plant-based thickening agent derived from cellulose. It helps control the texture and consistency of liquid or semi-solid medicines, and may also help keep ingredients evenly mixed throughout the product.
-
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
-
UNII 25X51I8RD4
Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
-
UNII HIE492ZZ3T
Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1.40 | $62.78 / 45 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metronidazole 10 mg/g 68308-0663-55 | Mayne | 1 bottle | $0.565 | AB | Availability likely | — |
| Metronidazole 10 mg/g 00713-0574-60 | Cosette | 1 tube | $0.621 | AB | Availability likely | — |
| Metronidazole 10 mg/g 51672-4215-03 | Sun | 1 tube | $0.621 | AB | Availability likely | — |
| Metronidazole 10 mg/g 59651-0813-60 | Aurobindo | 1 tube | $0.621 | AB | Availability likely | — |
| Metronidazole 10 mg/g 51672-4164-03 | Sun | 1 tube | $0.672 | AB | Discontinued | — |
| metronidazole 10 mg/g 66993-0936-58 | Prasco | 55 g | $0.866 | AB | Discontinued | — |
| Metronidazole 10 mg/gthis 46708-0630-45 | Alembic | 1 tube | — | AB | FDA listed | — |
| Metronidazole 10 mg/g 62332-0630-45 | Alembic | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 46708-0630-45 You're viewing this | 1 TUBE in 1 CARTON (46708-630-45) / 45 g in 1 TUBE | 2025-03-17 | Active |
| 46708-0630-55 | 1 BOTTLE, PUMP in 1 CARTON (46708-630-55) / 55 g in 1 BOTTLE, PUMP | 2025-03-17 | Active |
| 46708-0630-60 | 1 TUBE in 1 CARTON (46708-630-60) / 60 g in 1 TUBE | 2025-03-17 | Active |
Pack size FAQ
What quantity is in NDC 46708-0630-45?
What NDC number is used to bill for this package of Metronidazole 10 mg/g Gel?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Metronidazole gel, 1% is nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. Metronidazole gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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. Cleanse treated areas before the application of metronidazole gel ( 2 ) Apply and rub in a thin film of metronidazole gel once daily to affected area(s). ( 2 ) Cosmetics may be applied after the application of metronidazole gel.
( 2 ) Not for oral, ophthalmic or intravaginal use. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Gel, 1%. Metronidazole gel USP is a clear, colorless to pale yellow gel. Each gram of metronidazole gel USP contains 10 mg (1%) of metronidazole USP. Gel, 1%.
⛔ Contraindications ▾
4 CONTRAINDICATIONS Metronidazole gel is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation. Metronidazole gel is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Neurologic Disease: Peripheral neuropathy, characterized by numbness or paresthesia of an extremity has been reported in patients treated with systemic metronidazole. Peripheral neuropathy has been reported with the post approval use of topical metronidazole. Immediate reevaluate Metronidazole gel therapy if abnormal neurologic signs appear.
( 5.1 ) Blood Dyscrasias: Metronidazole gel is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia. ( 5.2 ) Contact Dermatitis: If dermatitis occurs, patients may need to discontinue use. ( 5.3 ) Eye Irritation: Topical metronidazole has been reported to cause tearing of the eyes.
Avoid contact with the eyes. ( 5.4 )
5.1Neurologic Disease Peripheral neuropathy, characterized by numbness or paresthesia of an extremity, has been reported in patients treated with systemic metronidazole. peripheral neuropathy has been reported with the post approval use of topical metronidazole. Immediately reevaluate metronidazole gel therapy if abnormal neurologic signs appear. Administer metronidazole with caution to patients with central nervous system diseases.
5.2Blood Dyscrasias Metronidazole gel is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia.
5.3Contact Dermatitis Irritant and allergic contact dermatitis have been reported with metronidazole gel. If dermatitis occurs, patients may need to discontinue use.
5.4Eye Irritation Topical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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)] Most common adverse reactions (incidence > 2%) are nasopharyngitis, upper respiratory tract infection, and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a controlled clinical trial, 557 subjects used metronidazole gel, 1% and 189 subjects used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occurred at a rate of ≥1% and at a higher rate than vehicle: Table 1: Adverse Reactions That Occurred at a Rate of ≥1% and Higher Than Vehicle in Subjects Treated with metronidazole gel for Up to 10 Weeks Preferred Term Metronidazole Gel, 1% Vehicle (N= 557) N (%) (N= 189) N (%) Influenza 8 (1.4) 1 (0.5) Upper respiratory tract infection 14 (2.5) 4 (2.1) Urinary tract infection 6 (1.1) 1 (0.5) Headache 12 (2.2) 1 (0.5) Contact dermatitis 7 (1.3) 1 (0.5) Hypertension 6 (1.1) 1 (0.5) Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline in Subjects Treated with metronidazole gel for Up to 10 Weeks Metronidazole Gel, 1% Vehicle Sign/Symptom (N= 544) N (%) (N= 184) N (%) Dryness 138 (25.4) 63 (34.2) Mild 93 (17.1) 41 (22.3) Moderate 42 (7.7) 20 (10.9) Severe 3 (0.6) 2 (1.1) Scaling 134 (24.6) 60 (32.6) Mild 88 (16.2) 32 (17.4) Moderate 43 (7.9) 27 (14.7) Severe 3 (0.6) 1 (0.5) Pruritus 86 (15.8) 35 (19.0) Mild 53 (9.7) 21 (11.4) Moderate 27 (5.0) 13 (7.1) Severe 6 (1.1) 1 (0.5) Stinging/burning 56 (10.3) 28 (15.2) Mild 39 (7.2) 18 (9.8) Moderate 7 (1.3) 9 (4.9) Severe 10 (1.8) 1 (0.5) The following additional adverse reactions have been reported with the topical use of metronidazole: transient redness, metallic taste, tingling or numbness of extremities, and nausea.
6.2Post marketing Experience The following adverse reaction has been identified during post-approval use of topical metronidazole. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. Nervous System Disorders: Peripheral neuropathy Ophthalmic Adverse Reactions: Tearing of the eyes
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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. Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time.
Use caution when administering metronidazole gel concomitantly to patients who are receiving anticoagulant treatment. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended.( 8.2 )
8.1Pregnancy Risk Summary Available data have not established an association between metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. No fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. The available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of metronidazole gel.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a 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 to 4% and 15 to 20%, respectively.
8.2Lactation Risk Summary It 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 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 metronidazole gel.
8.4Pediatric Use Safety and effectiveness of metronidazole gel have not been established in pediatric patients.
8.5Geriatric 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.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data have not established an association between metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. No fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. The available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of metronidazole gel.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a 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 to 4% and 15 to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of metronidazole gel have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism of action of metronidazole in the treatment of rosacea is unknown.
12.2Pharmacodynamics The pharmacodynamics of metronidazole in association with the treatment of rosacea are unknown. Cardiac Electrophysiology: The effect of metronidazole gel on the QTc interval has not been adequately characterized.
12.3Pharmacokinetics Topical administration of a one-gram dose of metronidazole gel to the face of 13 subjects with moderate to severe rosacea once daily for 7 days resulted in a mean ± SD C max of metronidazole of 32 ± 9 ng/mL. The mean ± SD AUC (0 to 24) was 595 ± 154 ng*hr/mL. The mean C max and AUC (0 to 24 ) are less than 1% of the value reported for a single 250 mg oral dose of metronidazole.
The time to maximum plasma concentration (T max ) was 6 to 10 hours after topical application.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism of action of metronidazole in the treatment of rosacea is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Metronidazole gel USP, 1% is clear, colorless to pale yellow in color, and supplied as follows: 45 gram tube- NDC 46708-630-45 60 gram tube- NDC 46708-630-60 55 gram pump- NDC 46708-630-55 Storage and Handling Store at 20˚ to 25˚C (68˚ to 77˚F); excursions permitted between 15˚ to 30˚C (59˚ to 86˚F) [see USP controlled room temperature].
📋 Description ▾
11 DESCRIPTION Metronidazole gel USP, 1% is a nitroimidazole for topical use. Metronidazole gel USP, 1% 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 C 6 H 9 N 3 O 3 . It has the following 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. Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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 Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216
💬 Patient Medication Information ▾
PATIENT INFORMATION PATIENT INFORMATION Metronidazole (MET-roe-NYE-da-zole) Gel, USP 1% 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 at 1-866-210-9797. 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 ingred…