Drug Catalog - Product Detail
CLINDAMYCIN PHOSPHATE/TRETINOIN 1.2/0.025% GEL 30GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68682-0300-30 | OCEANSIDE PHARMACEUTICALS | 30 | 1.2-0.025% | GEL |
PACKAGE FILES
Generic Name
CLINDAMYCIN PHOSPHATE AND TRETINOIN
Substance Name
CLINDAMYCIN PHOSPHATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA050802
Description
11 DESCRIPTION Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is an antibiotic and retinoid combination gel product with two active ingredients. 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: Clindamycin phosphate: Molecular Formula: C 18 H 34 ClN 2 O 8 PS Molecular Weight: 504.97 The chemical name for tretinoin 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 is represented below: Tretinoin: Molecular Formula: C 20 H 28 O 2 Molecular Weight: 300.44 Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel contains the following inactive ingredients: butylated hydroxytoluene NF, carbomer 981 NF, citric acid USP, edetate disodium USP, glycerin USP, methylparaben NF, polysorbate 80 NF, propylparaben NF, purified water USP and tromethamine USP. Chemical Structure Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is supplied as follows: 30 gram tube NDC 68682-300-30 60 gram tube NDC 68682-300-60 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 out of the reach of children. • Keep away from heat. • Keep tube tightly closed.
Indications & Usage
1 INDICATIONS AND USAGE Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel 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 1.2% and Tretinoin 0.025% Gel should be kept away from the eyes, the mouth, angles of the nose, and mucous membranes. Clindamycin Phosphate 1.2% and Tretinoin 0.025% 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 1.2% and Tretinoin 0.025% Gel is not for oral, ophthalmic, or intravaginal use. ( 2 )