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metronidazole 7.5 mg/g Lotion, 1 bottle — NDC 68308-0712-59 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

metronidazole 7.5 mg/g Lotion, 1 bottle — NDC 68308-712-59 (Billing 68308-0712-59)

by Mayne Pharma Inc. · 1 BOTTLE in 1 CARTON / 59.7 g in 1 BOTTLE

This is a package of 1 bottle of metronidazole 7.5 mg/g Lotion from Mayne Pharma Inc., marketed since Feb 2025 and currently FDA-listed; retail pharmacies pay about $1.82 per mL (NADAC). It is this product's only package size.

NDC 68308-0712-59
🏷️ FDA NDC (as labeled) 68308-712-59 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68308-712-59 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68308 labeler · 712 product · 59 package
Package marketed since
Feb 10, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6830871259 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68308-712-59
Product NDC 68308-712
11-digit billing NDC 68308071259
NCPDP billing unit ML — per mL (volume)
RxCUI 242736
UNII 140QMO216E
Application # NDA020901
SPL Set ID 5099691f-f216-4ac1-b057-99a845cc770f
Established class (EPC) Nitroimidazole Antimicrobial
Chemical class Nitroimidazoles
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-10
Route TOPICAL
Dosage form LOTION
Substance METRONIDAZOLE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90060040004110
GCN Seq No 041797
GCN 43201
HICL code 004157
Ingredient (HICL) Metronidazole
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5G
Therapeutic class — specific (HIC3) Rosacea Agents, Topical
AHFS code 08:30.04.00
AHFS class Amebicides
FDB label name METRONIDAZOLE 0.75% LOTION
FDB brand name Metronidazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 041797
  • GCN: 43201
  • GPI-14 (Medi-Span): 90060040004110
  • HICL (First Databank): 004157
  • AHFS class code: 08:30.04.00
  • RxCUI (RxNorm): 242736
Why two NDCs? The FDA registers this code as 68308-712-59 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68308-0712-59. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Nitroimidazole Antimicrobial class.

Pharmacologic class Nitroimidazole Antimicrobial
Drug family (ATC) Nitroimidazole derivatives, Antiinfectives and antiseptics for local oral treatment, Other chemotherapeutics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name METRONIDAZOLE 0.75% LOTION Ingredient Metronidazole
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Oral forms treat trichomoniasis, and some also treat amebiasis and anaerobic infections. Vaginal gels treat bacterial vaginosis, and topical cream or lot...
  • No. Alcohol with oral metronidazole can cause cramps, nausea, vomiting, headache and flushing. Avoid alcohol and products with propylene glycol during treatment and for at least th...
  • The most common are nausea, headache, loss of appetite, vomiting, diarrhea and stomach cramps. A metallic taste is also common. Call your doctor if you notice numbness or tingling,...
  • Yes. Metronidazole can interact with warfarin, lithium, busulfan, disulfiram and drugs that affect heart rhythm. Some of these combinations need blood tests or should be avoided, s...
📖 Read our full Metronidazole guide →
7
Nutrient depletion considerations

Metronidazole may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Metronidazole nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.817 —
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 $2.37 —
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $1.988 $1.792
▼ Down 4% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68308-0712-59 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 59.7 g in 1 BOTTLE 2025-02-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metronidazole 7.5 mg/g 00713-0637-37 Cosette 1 tube $0.179 AB Availability likely save 90%
Metronidazole 7.5 mg/g 72578-0209-04 Viona 1 tube $0.179 AB Availability likely save 90%
Metronidazole 7.5 mg/g 00713-0633-37 Cosette 1 tube $0.257 AB Availability likely save 86%
Metronidazole 7.5 mg/g 68308-0711-45 Mayne 1 tube $0.257 AB Availability likely save 86%
Metronidazole 7.5 mg/g 00168-0323-46 Fougera 45 g $0.257 AB Availability likely save 86%
Metronidazole 7.5 mg/g 59651-0770-46 Aurobindo 1 tube $0.257 AB Availability likely save 86%
Metronidazole 7.5 mg/g 66993-0960-45 Prasco 1 tube $0.257 AB Availability likely save 86%
Metronidazole 7.5 mg/g 72578-0129-08 Viona 1 tube $0.257 BX Availability likely save 86%
Metronidazole 7.5 mg/mL 00168-0383-60 Fougera 59 ml $1.817 AB Availability likely —
metronidazole 7.5 mg/gthis 68308-0712-59 Mayne 1 bottle $1.817 AB Availability likely —
Metronidazole 7.5 mg/g 51672-4116-02 Sun 1 tube — AB FDA listed —
Metronidazole 7.5 mg/g 70771-1834-04 Zydus 1 tube — BX FDA listed —
Metronidazole 7.5 mg/g 70771-1978-04 Zydus 1 tube — AB FDA listed —
Metronidazole 7.5 mg/g 68788-8552-04 Preferred 1 tube — BX FDA listed —
Metronidazole 7.5 mg/g 67296-2121-04 Redpharm 1 tube — AB FDA listed —
Metronidazole 7.5 mg/g 72162-2259-02 Bryant 45 g — AB FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

🧪 Avoiding an ingredient? See Metronidazole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMayne Pharma Inc.
Application holderGALDERMA LABORATORIES LP
FDA applicationNDA020901 (NDA AUTHORIZED GENERIC)
Labeler code68308
First marketedFeb 2025
Product typeHuman Prescription Drug
Portfolio29 products on file

More NDCs from Mayne Pharma Inc. labeler code 68308

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 21 words ▾

INDICATIONS AND USAGE Metronidazole Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

⏱️ Dosage and Administration 45 words ▾

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 MetronidazoleTopical Lotion to dry (not less than 5 minutes).

⛔ Contraindications 22 words ▾

CONTRAINDICATIONS Metronidazole Topical Lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.

🤒 Adverse Reactions 147 words ▾

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, MetronidazoleTopical Lotion 0, lotion vehicle 1 (1%); and worsening of rosacea, Metronidazole Topical Lotion 1 (1%), 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 35 words ▾

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 84 words ▾

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 12 words ▾

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

🧬 Clinical Pharmacology 128 words ▾

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 54 words ▾

HOW SUPPLIED Metronidazole Topical Lotion, 0.75% is supplied in the following size: 2 fl. oz. (59 mL) plastic bottle – NDC 68308- 712 -59 Storage: Store at controlled room temperature 68° - 77°F (20° - 25°C). Protect from freezing. Marketed By: Mayne Pharma Raleigh, NC 27609 1-844-825-8500 Product of Canada P58196-0 Revised Sept 2024

📦 Storage and Handling 30 words ▾

Storage: Store at controlled room temperature 68° - 77°F (20° - 25°C). Protect from freezing. Marketed By: Mayne Pharma Raleigh, NC 27609 1-844-825-8500 Product of Canada P58196-0 Revised Sept 2024

📋 Description 100 words ▾

DESCRIPTION Metronidazole Topical Lotion 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: metro-chem-struct

💬 Information for Patients 59 words ▾

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.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: Topical metronidazole formulations have been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use.

Metronidazole is a nitroimidazole and should be used with care in patients with evidence or history of blood dyscrasia. 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. 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. Carcinogenesis, Mutagenesis, Impairment of Fertility: Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats. Metronidazole has not been assessed for carcinogenic activity following topical administration.

In several long term studies in mice, oral doses of approximately 200 mg/m 2 /day (approximately 20 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of the body surface area)) or greater were associated with increase incidences of lung tumors in male mice and lymphomas in female mice. In several long-term studies in rats, oral administration of metronidazole resulted in increased incidences of mammary and hepatic tumors in female rats and testicular tumors and pituitary adenomas in male rats at dosages of approximately 1600 mg/m 2 /day (approximately 170 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of the body surface area)) or greater.

In another oral study, an increase of mammary tumors was observed in female rats that received approximately 160 mg/m 2 /day (approximately 17 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and the following normalization of the data on the basis of the body surface area)). Ultraviolet radiation-induced carcinogenesis was enhanced in albino mice by intraperitoneal injection of metronidazole at a dosage of 45 mg/m 2 /day, 5 days per week for 10 weeks, as indicated by a decreased latency period to the development of skin neoplasms.

It is unclear how this level of exposure compares to the clinical situation with respect to the concentration of the drug or metabolics in the skin. This study did not determine if metronidazole must be present during exposure to ultraviolet radiation in order to enhance tumor formation; metronidazole may promote tumor formation in cells that have previously been initiated by ultraviolet radiation. Metronidazole exhibited mutagenic activity in several in vitro bacterial and mammalian assay systems.

Intraperitoneal administration of metronidazole to mice resulted in a dosage-dependent increase in the incidence of chromosomal aberrations in peripheral lymphocytes was reported in patients with Crohn’s disease who were treated with metronidazole for 1 to 24 months at a dosage of 200 to 1200 mg/day. However, similar results were not observed in another study, in which humans were treated for 8 months. In rats, oral metronidazole at a dosage of approximately 1800 mg/m 2 /day (approximately 200 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and follow… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 64 words ▾

Nursing Mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics 106 words ▾

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.

🔬 Clinical Studies ~1 min read ▾

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 investigators' 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility: Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats. Metronidazole has not been assessed for carcinogenic activity following topical administration. In several long term studies in mice, oral doses of approximately 200 mg/m 2 /day (approximately 20 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of the body surface area)) or greater were associated with increase incidences of lung tumors in male mice and lymphomas in female mice.

In several long-term studies in rats, oral administration of metronidazole resulted in increased incidences of mammary and hepatic tumors in female rats and testicular tumors and pituitary adenomas in male rats at dosages of approximately 1600 mg/m 2 /day (approximately 170 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of the body surface area)) or greater. In another oral study, an increase of mammary tumors was observed in female rats that received approximately 160 mg/m 2 /day (approximately 17 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and the following normalization of the data on the basis of the body surface area)).

Ultraviolet radiation-induced carcinogenesis was enhanced in albino mice by intraperitoneal injection of metronidazole at a dosage of 45 mg/m 2 /day, 5 days per week for 10 weeks, as indicated by a decreased latency period to the development of skin neoplasms. It is unclear how this level of exposure compares to the clinical situation with respect to the concentration of the drug or metabolics in the skin. This study did not determine if metronidazole must be present during exposure to ultraviolet radiation in order to enhance tumor formation; metronidazole may promote tumor formation in cells that have previously been initiated by ultraviolet radiation.

Metronidazole exhibited mutagenic activity in several in vitro bacterial and mammalian assay systems. Intraperitoneal administration of metronidazole to mice resulted in a dosage-dependent increase in the incidence of chromosomal aberrations in peripheral lymphocytes was reported in patients with Crohn’s disease who were treated with metronidazole for 1 to 24 months at a dosage of 200 to 1200 mg/day. However, similar results were not observed in another study, in which humans were treated for 8 months.

In rats, oral metronidazole at a dosage of approximately 1800 mg/m 2 /day (approximately 200 times the exposure of a patient that received the estimated maximum human topical daily dose (assuming 100% bioavailability and following normalization of the data on the basis of body surface area)) induced inhibition of spermatogenesis and severe testicular degeneration.

📄 Package Label / Principal Display Panel 129 words ▾

PACKAGE LABEL NDC 68308- 712 -59 Metronidazole Lotion 0.75% Topical Lotion Rx Only 2 FL OZ (59 mL) maynepharma STORE AT CONTROLLED ROOM TEMPERATURE 68° TO 77° (20°-25°C). PROTECT FROM FREEZING. Distributed by: Mayne Pharma Raleigh, NC 27609 Product of Canada P58197-0 FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC USE. Usual Dosage: 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. Each gram contains: Active: metronidazole, 0.75% w/w (7.5 mg). Inactive: 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.

See lot number and expiration date on bottom of carton.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Metronidazole — the program that covers self-administered drugs. 23 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Metronidazole. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$12.08M
Claims incl. refills
571.7K
Beneficiaries
500.3K
Spend / beneficiary
$24.15
Spend / claim
$21.13
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 68308-0711-45 · Mayne 68308-0716-30 · Mayne →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.