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Clindagel (Clindamycin Phosphate Topical) - Indications and Dosage



In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used Clindagel ® (clindamycin phosphate topical gel, 1%) once daily or the vehicle gel once daily, in the treatement of acne vulgaris of mild to moderate severity, Clindagel® applied once daily was more effective than the vehicle applied once daily. The mean percent reductions in lesion counts at the end of treatment in this study are shown in the following table:

 Lesions  Clindagel® QD
 Vehicle Gel
 Inflammatory  51%  40% 1   
 Noninflammatory  25%  12%   
 Total  38%  27%  

1  P<0.05

There was a trend in the investigator's global assessment of the results which favored  Clindagel®  QD over the vehicle QD. 

In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to Clindagel®. There was no signal for contact sensitization in the clinical trials under normal use conditions.


Clindagel® is indicated for topical application in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate. (See CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS.)


Apply a thin film of Clindagel® once daily to the skin where acne lesions appear. Use enough to cover the entire affected area lightly.

Keep container tightly closed.


Clindagel® contaning clindamycin phosphate equivalent to 10 mg clindamycin per gram, is available in the following sizes:

75 mL bottle - NDC 16781-462-75

40 mL bottle - NDC 16781-462-40

7.3 mL bottle - NDC 16781-462-07 (physician's sample, not for resale)

Store under controlled room temperature 20oC - 25oC (68oF to 77oF); excursions permitted between 15oC- 30oC (59oF to 86oF). Do not store in direct sunlight.

US Patent No. 6,387,383

Marketed by: Onset Dermatologics, LLC, Cumberland, RI 02864

Manufactured by: DPT Laboratories, Ltd., San Antonio, Texas 78215 USA


P/N 2667 Rev.0



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