Label: BENZOYL PEROXIDE 2.5%, CLINDAMYCIN PHOSPHATE 1%, NIACINAMIDE 2% / TRETINOIN 0.05%- benzoyl peroxide 2.5%, clindamycin phosphate 1%, niacinamide 2% / tretinoin 0.05% gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72934-1012-2 - Packager: Sincerus Florida, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated May 3, 2019
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- Active, inactive
- NDC 72934-1012-2. BENZOYL PEROXIDE USP 2.5%, CLINDAMYCIN PHOSPHATE USP 1%, NIACINAMIDE USP 2% / TRETINOIN USP 0.05%. Gel30gm.
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INGREDIENTS AND APPEARANCE
BENZOYL PEROXIDE 2.5%, CLINDAMYCIN PHOSPHATE 1%, NIACINAMIDE 2% / TRETINOIN 0.05%
benzoyl peroxide 2.5%, clindamycin phosphate 1%, niacinamide 2% / tretinoin 0.05% gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72934-1012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 100 g TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN 0.05 g in 100 g CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN PHOSPHATE 1 g in 100 g BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g in 100 g Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72934-1012-2 30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/04/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/04/2019 Labeler - Sincerus Florida, LLC (080105003) Establishment Name Address ID/FEI Business Operations Sincerus Florida, LLC 080105003 manufacture(72934-1012)