RVP

Drug Catalog - Product Detail

CLINDAMYCIN PHOSPHATE FOAM FOAM 0.01 100GM

NDC Mfr Size Str Form
45802-0660-33 PADAGIS 100 1% FOAM
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PACKAGE FILES

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Generic Name
CLINDAMYCIN PHOSPHATE
Substance Name
CLINDAMYCIN PHOSPHATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA090785
Description
11 DESCRIPTION Clindamycin phosphate foam contains clindamycin (1%) as clindamycin phosphate. 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 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). The structural formula for clindamycin phosphate is represented below: Molecular Formula: C 18 H 34 CIN 2 O 8 PS Molecular Weight: 504.97 g/mol Clindamycin phosphate foam contains clindamycin (1%) as clindamycin phosphate, USP at a concentration equivalent to 10 mg clindamycin per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, ethanol (58%), polysorbate 60, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. clindamycin phosphate structural formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Clindamycin Phosphate Foam, 1% contains 10 mg of clindamycin as clindamycin phosphate, USP per gram. The white to off-white thermolabile foam is available as follows: • 50 gram aerosol can - NDC 45802- 660 -32 • 100 gram aerosol can - NDC 45802- 660 -33 16.2 Storage and Handling Store at 20º to 25°C (68º to 77°F) [See USP Controlled Room Temperature]. Flammable. Avoid fire, flame or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperature above 120°F (49°C). Keep out of reach of children.
Indications & Usage
1 INDICATIONS AND USAGE Clindamycin phosphate foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older. Clindamycin phosphate foam is a lincosamide product indicated for acne vulgaris in patients 12 years and older. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Clindamycin phosphate foam is for topical use only, and not for oral, ophthalmic or intravaginal use. Apply clindamycin phosphate foam once daily to affected areas after the skin is washed with mild soap and allowed to fully dry. Use enough to cover the entire affected area. If there has been no improvement after 6 to 8 weeks or if the condition becomes worse, treatment should be discontinued. The contents of clindamycin phosphate foam are flammable; avoid fire, flame and/or smoking during and immediately following application. • For topical use only; not for oral, ophthalmic, or intravaginal use. ( 2 ) • Apply clindamycin phosphate foam once daily to affected areas. ( 2 ) • Flammable; avoid fire, flame and/or smoking during and immediately following application. ( 2 )