Application Nr Approved Date Route Status External Links
ANDA090979 None Topical None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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