SkinActive ingredient
Metronidazole
Topical antibacterial1 FDA label read
Topical metronidazole is one of the two long-established prescription treatments for rosacea. It is the same molecule used as an oral antibiotic for infections, but the topical gel is a separate approval and is applied to the skin rather than swallowed.
Highlights of the labels
- Metronidazole topical gel
- Papules and pustules of rosaceacovers skin
- Supply
- Prescription only
- Generic
- 38 approved applications
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| Metronidazole topical gelEncube Ethicals, Inc. | What its label approvesPapules and pustules of rosaceaCovers skin | SupplyPrescription | Label version12 September 2025 |
How it works
Topical metronidazole has been prescribed for rosacea for a long time, and its label still does not claim to know why it helps. That is worth noticing rather than glossing over: approval rests on what the trials showed, not on a settled explanation, and the regulator says so plainly in the wording below.
Mechanism of action, Metronidazole topical gel label
The mechanisms by which metronidazole gel USP (topical), 0.75%, acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
What the FDA approved it for
The approved uses, as worded in the label.
Metronidazole gel USP (topical), 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Forms and strengths
The presentations and strengths listed in the label.
Metronidazole gel USP (topical), 0.75%, is supplied as the following: NDC 21922-070-06: 45 g aluminum lube Storage conditions: Store at 20° to 25°C (68° to 77°F).
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- Apply and rub in a thin film of metronidazole gel USP (topical), 0.75%, twice daily, morning and evening, to entire affected areas after washing.
- Areas to be treated should be cleansed before application of metronidazole gel USP (topical), 0.75%.
- Patients may use cosmetics after application of metronidazole gel USP (topical), 0.75%.
Most common adverse reactions
The adverse reactions the label reports as most common.
The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
Contraindications
Situations in which the label states the medication must not be used.
Metronidazole gel USP (topical), 0.75%, is contraindicated in individuals with a history of hypersensitivity lo metronidazole, parabens, or other ingredients of the formulation.
Drug interactions
Interactions the label singles out.
- Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time.
- The effect of topical metronidazole on prothrombin time is not known.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Teratogenic effects Teratogenic effects: Pregnancy category B: There has been no experience to date with the use of metronidazole gel USP (topical), 0.75%, in pregnant patients. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice.
Generic or brand
Generic topical metronidazole gel, cream and lotion are approved and widely available.
The FDA label database lists 38 approved generic applications for this ingredient.
What affects the cost
This is an old generic and among the least expensive prescription options in this category. This site does not link to sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Generic |
|---|---|
| per gram | Generic$0.301 (range $0.141 to $0.705, 771 listings) |
| per milliliter | Generic$1.90 (range $1.81 to $1.99, 67 listings) |
Median of 838 listings. Effective dates 2025-12-17 to 2026-07-22, file dated 2026-07-29.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Does the label explain how it works in rosacea?
- No, and it says so. The label states that the mechanism of action in inflammatory lesions of rosacea is unknown. Approval rests on the trial results, not on a mechanism.
Other medications under skin
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Metronidazole topical gel
Encube Ethicals, Inc.. Label version 2, effective 12 September 2025.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 23 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.