Drug Catalog - Product Detail
Metronidazole Lotion 0.75% 59 ML UoU
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 66993-0961-59 | PRASCO LABORATORIES | 59 | 0.75% | NA |
PACKAGE FILES
Generic Name
METRONIDAZOLE
Substance Name
METRONIDAZOLE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA020901
Description
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
How Supplied
HOW SUPPLIED Metronidazole Topical Lotion, 0.75% is supplied in the following size: 2 fl. oz. (59 mL) plastic bottle – NDC 66993-961-59 Storage: Store at controlled room temperature 68° - 77°F (20° - 25°C). Protect from freezing. Marketed By: Prasco Laboratories Mason, OH 45040 USA Made in Canada P53362-0 Revised: January 2017
Indications & Usage
INDICATIONS AND USAGE Metronidazole Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
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 MetronidazoleTopical Lotion to dry (not less than 5 minutes).