Drug Catalog - Product Detail
ERYTHROMYCIN GEL GEL 0.02 30GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0966-94 | PADAGIS | 30 | 2% | GEL |
PACKAGE FILES
Generic Name
ERYTHROMYCIN
Substance Name
ERYTHROMYCIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA063211
Description
DESCRIPTION Erythromycin Topical Gel USP, 2% contains erythromycin (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3- C -methyl-3- O -methyl-α-L- ribo -hexopyranosyl)oxy]-14-ethyl-7, 12, 13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6,-trideoxy-3-(dimethylamino)-β-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione), for topical dermatological use. Erythromycin is a macrolide antibiotic produced from a strain of Saccaropolyspora erythraea (formerly Streptomyces erythreus ). It is a base and readily forms salts with acids. Chemically, erythromycin is C 37 H 67 NO 13 . It has the following structural formula: Erythromycin has a molecular weight of 733.94. It is a white or slightly yellow, odorless or practically odorless, bitter crystalline powder. Erythromycin is very soluble in very polar organic solvents such as alcohols, acetone, chloroform, acetonitrile and ethyl acetate. It is moderately soluble in less polar solvents such as ether, dichloroethylene and amyl acetate. It is slightly soluble in nonpolar solvents such as hexane. It is very poorly soluble in water. Each gram of Erythromycin Topical Gel USP, 2% contains 20 mg of erythromycin USP in a vehicle consisting of dehydrated alcohol and hydroxypropyl cellulose. structure
How Supplied
HOW SUPPLIED Erythromycin Topical Gel USP, 2% is available as follows: 30 g sealed metal tube (NDC 45802- 966 -94) 60 g sealed metal tube (NDC 45802- 966 -96)
Indications & Usage
INDICATIONS AND USAGE Erythromycin Topical Gel USP, 2% is indicated for the topical treatment of acne vulgaris.
Dosage and Administration
DOSAGE AND ADMINISTRATION Erythromycin Topical Gel USP, 2% should be applied sparingly as a thin film to affected area(s) once or twice a day after the skin is thoroughly cleansed and patted dry. If there has been no improvement after 6 to 8 weeks, or if the condition becomes worse, treatment should be discontinued, and the physician should be reconsulted. Spread the medication lightly rather than rubbing it in. There are no data directly comparing the safety and efficacy of b.i.d. versus q.d. dosing.