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BenzaClin

Indications & Dosage
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INDICATIONS

BenzaClin Topical Gel is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATION

BenzaClin Topical Gel 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.

HOW SUPPLIED

Compounding Instructions

Size
(Net Weight)
NDC 0066- Benzoyl Peroxide Gel Active Clindamycin Powder (In plastic vial) Purified Water To Be Added to each vial
25 grams 0494-25 19.7g 0.3g 5 mL
50 grams 0494-50 41.4g 0.6g 10 mL
50 grams (pump) 0494-55 41.4g 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 50 gram pump only, reassemble jar with pump dispenser. BenzaClin Topical Gel (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.

Store at room temperature up to 25ºC (77ºF) {See USP}.

Do not freeze. Keep tightly closed. Keep out of the reach of children.

US Patents 5,446,028; 5,767,098; 6,013,637
Prescribing Information as of August 2006.
Dermik Laboratories., a business of sanofi-aventis U.S. LLC Bridgewater, NJ 08807
Country of Origin: Canada
©2006 sanofi-aventis U.S. LLC
FDA rev date: 5/23/2007

Brand Name: BenzaClin
Generic Name: Clindamycin & Benzoyl Peroxide

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