Drug Catalog - Product Detail
CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE GEL GEL 1.2/5% 45GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0736-84 | PADAGIS | 45 | 1.2-5% | GEL |
PACKAGE FILES
Generic Name
CLINDAMYCIN, BENZOYL PEROXIDE
Substance Name
BENZOYL PEROXIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA090979
Description
11 DESCRIPTION Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a fixed combination product with two active ingredients in a white, opaque, aqueous gel formulation. 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. Clindamycin phosphate is C 18 H 34 ClN 2 O 8 PS. The structural formula for clindamycin phosphate is represented below: Clindamycin phosphate has a molecular weight of 504.97 and its chemical name 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). Benzoyl peroxide is C 14 H 10 O 4 . It has the following structural formula: Benzoyl peroxide has a molecular weight of 242.23. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% contains 10 mg (1%) clindamycin, as clindamycin phosphate, and 50 mg (5%) benzoyl peroxide in a base consisting of carbomer homopolymer (type B), hydrochloric acid, methylparaben, dimethicone, propylparaben, purified water and sodium hydroxide. structural-formula structural_formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a white, opaque gel. It is supplied as follows: • 45 gram tube NDC 45802- 736 -84 16.2 Storage and Handling Pharmacist: • Prior to Dispensing: Store in a cold place, preferably in a refrigerator, between 2°C and 8°C (36°F and 46°F). Do not freeze. 16.3 Dispensing Instructions for the Pharmacist • Dispense Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% with a 60-day expiration date. • Specify “Store at room temperature up to 25°C (77°F). Do not freeze.” • Keep tube tightly closed. • Keep out of the reach of small children.
Indications & Usage
1 INDICATIONS AND USAGE Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. ( 1.1 ) Limitation of Use: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. ( 1.2 ) 1.1 Indication Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. 1.2 Limitations of Use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Apply a thin layer of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% to the face once daily, in the evening or as directed by the physician. The skin should be gently washed, rinsed with warm water, and patted dry before applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is not for oral, ophthalmic, or intravaginal use. • Apply a thin layer of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% to the face once daily, in the evening. ( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )