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Drug Catalog - Product Detail

CLINDAMYCIN PHOSPHATE/TRETINOIN GEL GEL 1.2/0.025% 60GM

NDC Mfr Size Str Form
00472-1790-60 ACTAVIS MID ATLANTIC 60 1.2-0.025% GEL
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PACKAGE FILES

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Generic Name
CLINDAMYCIN PHOSPHATE AND TRETINOIN
Substance Name
CLINDAMYCIN PHOSPHATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA202564
Description
11 DESCRIPTION Clindamycin phosphate and tretinoin gel 1.2% / 0.025%, is an antibiotic and retinoid combination gel product with two active ingredients. Clindamycin phosphate, USP 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, USP 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, USP is represented below: Clindamycin phosphate, USP: Molecular Formula: C 18 H 34 ClN 2 O 8 PS Molecular Weight: 504.97 The chemical name for tretinoin, USP is 3,7-Dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8- nonatetraenoic acid (all- trans form). The structural formula for tretinoin, USP is represented below: Tretinoin, USP: Molecular Formula: C 20 H 28 O 2 Molecular Weight: 300.44 Clindamycin phosphate and tretinoin gel 1.2% / 0.025% contains the following inactive ingredients: anhydrous citric acid, butylated hydroxytoluene, edetate disodium, hydroxyethyl cellulose, glycerin, methylparaben, polysorbate 80, propylparaben, purified water, tromethamine and xanthan gum. 12f9b5a2-figure-01 12f9b5a2-figure-02
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is supplied as follows: 30 gram tube NDC 0472-1790-30 60 gram tube NDC 0472-1790-60 Storage and Handling Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from light. Protect from freezing. Keep away from heat. Keep tube tightly closed. Keep out of the reach of children.
Indications & Usage
1 INDICATIONS AND USAGE Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin phosphate and tretinoin gel 1.2% / 0.025% is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years or older. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION At bedtime, squeeze a pea-sized amount of medication onto one fingertip, dot onto the chin, cheeks, nose, and forehead, then gently rub over the entire face. Clindamycin phosphate and tretinoin gel should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. Clindamycin phosphate and tretinoin gel is not for oral, ophthalmic, or intravaginal use. Apply a pea-sized amount to the entire face once daily at bedtime. Do not apply to eyes, mouth, angles of the nose, or mucous membranes. ( 2 ) Clindamycin phosphate and tretinoin gel is not for oral, ophthalmic, or intravaginal use. ( 2 )