Drug Catalog - Product Detail
CLINDAMYCIN PHOS BENZOYL PER GEL 1.2%/2.5% 50GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68682-0132-50 | OCEANSIDE PHARMACEUTICALS | 50 | 1.2-2.5% | GEL |
PACKAGE FILES
Generic Name
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Substance Name
BENZOYL PEROXIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA050819
Description
11 DESCRIPTION Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% is a combination product with two active ingredients in a white to off-white, opaque, smooth, aqueous gel formulation intended for topical use. Clindamycin phosphate is a water-soluble ester of the semisynthetic 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 Benzoyl peroxide is an antibacterial and keratolytic agent. The structural formula for benzoyl peroxide is represented below: Benzoyl peroxide: Molecular Formula: C 14 H 10 O 4 Molecular Weight: 242.23 Clindamycin Phosphate and Benzoyl Peroxide Gel contains the following inactive ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel contains 1.2% of clindamycin phosphate which is equivalent to 1% clindamycin. chem1 chem2
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, a white to off-white smooth gel is supplied as: NDC 68682-132-50 50 g pump 16.2 Dispensing Instructions for the Pharmacist • Dispense Clindamycin Phosphate and Benzoyl Peroxide Gel with a 10-week expiration date. • Specify "Store at room temperature up to 25°C (77°F). Do not freeze." 16.3 Storage and Handling • PHARMACIST: Prior to Dispensing: Store in a refrigerator, 2° to 8°C (36° to 46°F). • PATIENT: Store at room temperature at or below 25°C (77°F). • Protect from freezing. • Store pump upright. • Keep out of the reach of children. • Keep container tightly closed.
Indications & Usage
1 INDICATIONS AND USAGE Clindamycin Phosphate and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin Phosphate and Benzoyl Peroxide Gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years or older. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Before applying Clindamycin Phosphate and Benzoyl Peroxide Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry. Apply a pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel to the face once daily. Avoid the eyes, mouth, mucous membranes, or areas of broken skin. Use of Clindamycin Phosphate and Benzoyl Peroxide Gel beyond 12 weeks has not been evaluated. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Clindamycin Phosphate and Benzoyl Peroxide Gel is not for oral, ophthalmic, or intravaginal use. • Apply a pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel to the face once daily. ( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )