Drug Catalog - Product Detail
CLINDAMYCIN PHOSPHATE PLEDGETS PADS 0.01 60
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0263-37 | PADAGIS | 60 | 1% | SWAB |
PACKAGE FILES
Generic Name
CLINDAMYCIN PHOSPHATE
Substance Name
CLINDAMYCIN PHOSPHATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA065049
Description
DESCRIPTION Clindamycin Phosphate Topical Solution contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Each Clindamycin Phosphate Topical Solution pledget applicator contains approximately 1 mL of topical solution. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The solution contains isopropyl alcohol 50% v/v, propylene glycol, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0). The structural formula is represented below: The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans -4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo -α-D- galacto -octopyranoside 2-(dihydrogen phosphate) structural formula image
How Supplied
HOW SUPPLIED Clindamycin Phosphate Topical Solution USP, 1% is available as follows: A jar containing 60 single-use pledget applicators (NDC 45802- 263 -37) A jar containing 69 single-use pledget applicators (NDC 45802- 263 -93)
Indications & Usage
INDICATIONS AND USAGE Clindamycin Phosphate Topical Solution USP, 1% is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).
Dosage and Administration
DOSAGE AND ADMINISTRATION Do not use if the seal on jar is broken. Remove pledget from jar just before use. Use a pledget to apply a thin film of Clindamycin Phosphate Topical Solution to the affected area twice daily. More than one pledget may be used. Each pledget should be used only once and then discarded. Keep jar tightly closed when not in use.