Metronidazole 7.5 mg/mL Lotion, 59 mL
🆔 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 LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
-
UNII F68VH75CJC
A synthetic polymer made from acrylic acid that thickens and stabilizes liquid or gel formulations. It's used as a gelling agent and emulsifier to create the desired texture and consistency in topical medicines.
-
UNII NMQ347994Z
Cyclomethicone is a silicone-based fluid that acts as a lubricant and solvent in medicines. It helps products flow smoothly, reduces friction between particles, and aids in even distribution of active ingredients.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
-
UNII 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
-
UNII N6K5787QVP
Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
-
UNII YD01N1999R
A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
-
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
-
UNII 1VPU26JZZ4
Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
-
UNII 53J3F32P58
A synthetic detergent derived from stearic acid, a fatty substance. It helps dissolve or distribute oil-based ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer in tablets and capsules.
-
UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
-
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.
14 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.792 | $105.75 / 59 ml |
| Medicaid paysCMS SDUD · 12 mo | $1.99 | $117.64 / 59 ml |
| Medicare drug plans payPart D · Q2 2026 | $2.37 | $140.01 / 59 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metronidazole 7.5 mg/mLthis 00168-0383-60 | Fougera | 59 ml | $1.792 | AB | Availability likely | — |
| metronidazole 7.5 mg/g 68308-0712-59 | Mayne | 1 bottle | $1.792 | AB | Availability likely | — |
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?
🗺️ Medicaid utilization & spend
📊 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 |
|---|---|---|---|
| 00168-0383-60 You're viewing this | 59 mL in 1 BOTTLE, PLASTIC (0168-0383-60) | 2006-05-24 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Metronidazole topical lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. CLINICAL STUDIES A controlled clinical study was conducted in 144 patients with moderate to severe rosacea, in which metronidazole topical lotion was compared with its vehicle. Applications were made twice daily for 12 weeks during which patients were instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages, and caffeine.
Patients were also provided samples of a soapless cleansing lotion and, if requested, a moisturizer. Metronidazole topical lotion was significantly more effective than its vehicle in mean percent reduction of inflammatory lesions associated with rosacea and in the investigator's global assessment of improvement. The results of the mean percent reduction in inflammatory lesion counts from baseline after 12 weeks of treatment and the investigators' global assessment of improvement at week 12 are presented in the following table: Efficacy Outcomes at Week 12 Mean Percent Reduction in Inflammatory Lesion Counts from Baseline Metronidazole Topical Lotion N=65 Vehicle Lotion N=60 55% 20% Investigators' Global Assessment of Improvement (percent change from baseline) Worse No Change Minimal Improvement Definite Improvement Marked Improvement Clear Metronidazole Topical Lotion N=65 5% 12% 11% 32% 32% 8% Vehicle Lotion N=60 15% 27% 23% 15% 20% 0% The scale is based on the following definitions: Worse: Exacerbation of either erythema or quantitative assessment of papules and/or pustules.
No Change: Condition remains the same. Minimal Improvement: Slight improvement in the quantitative assessment of papules and/or pustules, and/or slight improvement in erythema. Definite Improvement: More pronounced improvement in the quantitative assessment of papules and/or pustules, and/or more pronounced improvement in erythema.
Marked Improvement: Obvious improvement in the quantitative assessment of papules and/or pustules, and/or obvious improvement in erythema. Clear: No papules or pustules and minimal residual or no erythema.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Apply a thin layer to entire affected areas after washing. Use morning and evening or as directed by physician. Avoid application close to the eyes. Patients may use cosmetics after waiting for the metronidazole topical lotion to dry (not less than 5 minutes).
⛔ Contraindications ▾
CONTRAINDICATIONS Metronidazole topical lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In a controlled clinical trial, safety data from 141 patients who used metronidazole topical lotion (n=71), or the lotion vehicle (n=70), twice daily and experienced a local cutaneous adverse event which may or may not have been related to the treatments include: local allergic reaction, metronidazole topical lotion 2 (3%), lotion vehicle 0; contact dermatitis, metronidazole topical lotion 2 (3%), lotion vehicle 1 (1%); pruritus, metronidazole topical lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), metronidazole topical lotion 1 (1%), lotion vehicle 2 (3%); erythema, metronidazole topical lotion 4 (6%), lotion vehicle 0; dry skin, metronidazole topical lotion 0, lotion vehicle 1 (1%); and worsening of rosacea, metronidazole topical lotion 1 (1%), and lotion vehicle 7 (10%).
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.
🔄 Drug Interactions ▾
Drug Interactions Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
🤰 Pregnancy ▾
Pregnancy: Teratogenic Effects: Pregnancy Category B There are no adequate and well-controlled studies with the use of metronidazole topical lotion 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.
However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect. Pharmacokinetics Absorption of metronidazole after topical application of metronidazole topical lotion is less complete and more prolonged than after oral administration. Detectable plasma levels were found in all subjects following the administration of a 1 gram dose of metronidazole topical lotion (containing 7.5 mg of metronidazole) applied every morning and evening for 4 days to the faces of 8 patients.
The highest concentration (96 ng/mL) seen following the morning dose on Day 5 was approximately 80 times lower than the peak concentrations produced by a single 250 mg tablet of metronidazole. The mean (± SD) AUC 0-24 after twice daily administration was 962 ± 373 ng.hr/mL.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Metronidazole Topical Lotion, 0.75% is supplied in the following size: 2 Fl Oz (59 mL) plastic bottle – NDC 0168-0383-60 Store at controlled room temperature, 20°to 25°C (68° to 77°F). Protect from freezing. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I2383C/IF2383C R07/16 #124
📋 Description ▾
DESCRIPTION Metronidazole Topical Lotion, 0.75% contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75% w/w) in a lotion consisting of benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH. Metronidazole is an imidazole and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1 H -imidazole-1-ethanol.
The molecular formula is C 6 H 9 N 3 O 3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula: Structural Formula
💬 Information for Patients ▾
Information for Patients Patients using metronidazole topical lotion should receive the following information and instructions: 1. This medication is to be used only as directed by the physician. 2. It is for external use only. 3. Avoid contact with the eyes. 4. Cleanse affected area(s) before applying this medication. 5. Patients should report any adverse reaction to their physician.