Metronidazole
Generic: METRONIDAZOLE
Basic Information
Manufacturer
Cosette Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
de4cb39f-cc6e-98fb-05e5-103f3aca2dad
Indications & Usage
INDICATIONS AND USAGE Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Adverse Reactions
ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of Metronidazole Topical Cream was approximately10%.
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 Cosette Pharmaceuticals, Inc.
at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 Cosette Pharmaceuticals, Inc.
at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.