Drug Catalog - Product Detail
CLINDAMYCIN/BENZOYL PEROXIDE GEL GEL 1/5% 50GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0507-02 | PADAGIS | 50 | 1-5% | GEL |
PACKAGE FILES
Generic Name
CLINDAMYCIN AND BENZOYL PEROXIDE
Substance Name
Product Type
HUMAN PRESCRIPTION DRUG
Route
Application Number
ANDA202440
Description
DESCRIPTION Clindamycin and benzoyl peroxide topical gel, 1%/5% contains clindamycin phosphate, (7(S)-chloro-7-deoxylincomycin-2-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. Chemically, clindamycin phosphate is (C 18 H 34 ClN 2 O 8 PS). The structural formula for clindamycin 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-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate). Clindamycin and benzoyl peroxide topical gel, 1%/5% also contains benzoyl peroxide, for topical use. Chemically, 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 and benzoyl peroxide topical gel, 1%/5% contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer homopolymer type C, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water. Chemical Structure Chemical Structure
How Supplied
HOW SUPPLIED AND COMPOUNDING INSTRUCTIONS Size (Net Weight) NDC 45802 Benzoyl Peroxide Gel Active Clindamycin Powder (In plastic vial) Purified Water To Be Added to each vial 25 grams 509 -01 19.7g 0.3g 5 mL 35 grams (pump) 510 -03 27.6g 0.4g 7 mL 50 grams 507 -02 39.4g 0.6g 10 mL 50 grams (pump) 507 -04 39.4g 0.6g 10 mL Prior to dispensing, tap the vial until powder flows freely. Add indicated amount of purified water to the vial (to the mark) and immediately shake to completely dissolve clindamycin. If needed, add additional purified water to bring level up to the mark. Add the solution in the vial to the gel and stir until homogenous in appearance (1 to 1½ minutes). For the 35 and 50 gram pumps only, reassemble jar with pump dispenser. Clindamycin and benzoyl peroxide topical gel, 1%/5% (as reconstituted) can be stored at room temperature up to 25°C (77°F) for 3 months. Place a 3 month expiration date on the label immediately following mixing.
Indications & Usage
INDICATIONS AND USAGE Clindamycin and benzoyl peroxide topical gel, 1%/5% is indicated for the topical treatment of acne vulgaris.
Dosage and Administration
DOSAGE AND ADMINISTRATION Clindamycin and benzoyl peroxide topical gel, 1%/5% should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is gently washed, rinsed with warm water and patted dry.