Rx Item-Benzaclin 1% 5% Gel 25gm by Valeant Pharma

BENZACLIN- clindamycin phosphate and benzoyl peroxide gel
Dermik Laboratories


Topical Gel: clindamycin (1%) as clindamycin phosphate, benzoyl peroxide (5%)

For Dermatological Use Only � Not for Ophthalmic Use

*Reconstitute Before Dispensing*

DESCRIPTION

BenzaClin� Topical Gel 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 (C18 H34 ClN2 O8 PS). The structural formula for clindamycin is represented below:

Chemical Structure
(click image for full-size original)
Clindamycin phosphate has 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).

BenzaClin Topical Gel also contains benzoyl peroxide, for topical use.Chemically, benzoyl peroxide is (C14 H10 O4 ). It has the following structural formula:

Chemical Structure
Benzoyl peroxide has a molecular weight of 242.23.

Each gram of BenzaClin Topical Gel contains, as dispensed, 10 mg (1%) clindamycin as phosphate and 50 mg (5%) benzoyl peroxide in a base of carbomer, sodium hydroxide, dioctyl sodium sulfosuccinate, and purified water.

CLINICAL PHARMACOLOGY

An in vitro percutaneous penetration study comparing BenzaClin Topical Gel and topical 1% clindamycin gel alone, demonstrated there was no statistical difference in penetration between the two drugs. Mean systemic bioavailability of topical clindamycin in BenzaClin Topical Gel is suggested to be less than 1%.

Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid. Less than 2% of the dose enters systemic circulation as benzoic acid. It is suggested that the lipophilic nature of benzoyl peroxide acts to concentrate the compound into the lipid-rich sebaceous follicle.

Microbiology
The clindamycin and benzoyl peroxide components individually have been shown to have in vitro activity against Propionibacterium acnes an organism which has been associated with acne vulgaris; however, the clinical significance of this activity against P. acnes was not examined in clinical trials with this product.

Benzaclin 1% 5% Gel 25gm by Valeant Phar
NDC No. 00187-5190-25 UPC/GTIN No. 3-01875-19025-5 MPN 519025 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Thera

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Valeant Pharma

CLINDAMYCIN PHOS/BENZOYL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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