Indications and uses
Metronidazole topical cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Metronidazole Topical Cream, 0.75% Rx only
- Manufacturer
- Aurobindo Pharma Limited | APL HEALTHCARE LIMITED
- Effective date
- 2025-07-11
- Label type
- Human Prescription Drug Label
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 21:37:52
Label at a glance#
ProductMetronidazole
Active ingredientMETRONIDAZOLE
Label structure11 sections
Dosage and administration
Apply and rub in a thin layer of metronidazole topical cream twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of metronidazole topical cream.
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
FOR TOPICAL USE ONLY
(NOT FOR OPHTHALMIC USE)
DESCRIPTION:
Metronidazole topical cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, lactic acid and sodium hydroxide to adjust pH, purified water and sorbitol solution. Metronidazole is a member of the imidazole class of antibacterial agents 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 C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:
CLINICAL PHARMACOLOGY:
The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
INDICATIONS AND USAGE:
Metronidazole topical cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
CONTRAINDICATIONS:
Metronidazole topical cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.
PRECAUTIONS:
General:
Topical metronidazole has 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 of, or history of blood dyscrasia.
Information for patients:
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
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 but not in studies involving hamsters.
Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn’s disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.
Pregnancy:
Teratogenic effects: There are no adequate and well-controlled studies with the use of metronidazole topical cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral 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.
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.
Pediatric use:
Safety and effectiveness in pediatric patients have not been established.
ADVERSE REACTIONS:
In controlled clinical trials, the total incidence of adverse reactions associated with the use of metronidazole topical cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients.
The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION:
Apply and rub in a thin layer of metronidazole topical cream twice daily, morning and evening, to entire affected areas after washing.
Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of metronidazole topical cream.
HOW SUPPLIED:
Metronidazole Topical Cream, 0.75% is supplied in a:
45 g aluminum tube NDC 59651-770-46
Storage conditions: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Issued: March 2025
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Label
NDC 59651-770-46
Rx only
Metronidazole Topical Cream
0.75%
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
AUROBINDO NET WT. 45 g
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
NDC 59651-770-46
Rx only
Metronidazole Topical Cream
0.75%
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
AUROBINDO NET WT. 45 g
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| METRONIDAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55 | Product name | 5 | 20251024 |
| 7f6d14e0-4366-41bc-a4a9-b74c79a20e17 | Product name | 1 | 20250623 |
| e6d321b0-0e5e-7da6-f043-92b6a91f00a1 | Product name | 5 | 20250515 |
| e1aac33b-94ae-4ee9-905b-299f7263853b | Product name | 3 | 20250124 |
| 16642716-d28a-4f90-8dcb-3921cd8c8109 | Product name | 4 | 20240516 |
| 0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15 | Product name | 1 | 20240313 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| a5070875-62bb-61e1-fd46-8f7054197a40 | Product name | 8 | 20180215 |
| 0add4de9-d152-3375-3390-1123dddc5e3d | Product name | 1 | 20140508 |
| 33ca0fcc-1011-92dc-50a9-a383683eed1e | Product name | 1 | 20140508 |
| 53f39d9f-cd3f-04e1-c668-d4580719d57d | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
| a804000f-b74f-0b5d-d17b-aa767c286ddb | Product name | 1 | 20140508 |
| a91ea265-6e02-c08f-93c8-686d54180529 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59651-770-46 | Metronidazole | 45 g in 1 TUBE | CREAM | 45 | 1 | |
| 59651-770-46 | Metronidazole | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59651-770-46 | GM - Gram | 59651-770 | 03f66e10-049b-4f3e-aa2d-7a04024872fb | 1 | 2026-02-05 |
Products#
Every source-derived product name is available through these pages.
- Metronidazole
- BENZYL ALCOHOL
- GLYCERIN
- ISOPROPYL PALMITATE
- LACTIC ACID, UNSPECIFIED FORM
- SODIUM HYDROXIDE
- WATER
- SORBITOL SOLUTION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59651-770 | 59651-770-46 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METRONIDAZOLE | 140QMO216E | ACTIB |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ISOPROPYL PALMITATE | 8CRQ2TH63M | IACT |
| LACTIC ACID, UNSPECIFIED FORM | 33X04XA5AT | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219295-001 | METRONIDAZOLE | METRONIDAZOLE | 0.75% | CREAM / TOPICAL | AB | 2025-07-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219295-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A219295-001 | METRONIDAZOLE | 0.75% | CREAM / TOPICAL | AB | 2025-07-09 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A219295-001 | METRONIDAZOLE | 0.75% | CREAM / TOPICAL | AB | 2025-07-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A219295-001 | METRONIDAZOLE | 0.75% | CREAM / TOPICAL | AB | 2025-07-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219295-001 | METRONIDAZOLE | 0.75% | CREAM / TOPICAL | AB | 2025-07-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219295-001 | METRONIDAZOLE | 0.75% | CREAM / TOPICAL | AB | 2025-07-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219295-001 | METRONIDAZOLE | 0.75% | CREAM / TOPICAL | AB | 2025-07-09 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219295-001 | METRONIDAZOLE | 0.75% | CREAM / TOPICAL | AB | 2025-07-09 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A219295-001 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A219295-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A219295-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A219295-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219295-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A219295-001 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219295-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metronidazole | METRONIDAZOLE | Aurobindo Pharma Limited | 0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74 | 2025-07-11 | Adverse reactions | 59651-770-46 59651-770 59651077046 0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74 0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.