Label: BENZOYL PEROXIDE 5% / CLINDAMYCIN1% / NIACINAMIDE 2% / TRETINOIN 0.025% gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 25, 2019

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  • directions for use

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  • Sincerus Florida, LLC adverse reactions.

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  • Active, inactive

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  • NDC 72934-1020-2 Benzoyl Peroxide 5 / Clindamicyn 1 / Niacinamide 2/ Tretinoin 0.025 % gel 30gm

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  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 5% / CLINDAMYCIN1% / NIACINAMIDE 2% / TRETINOIN 0.025% 
    benzoyl peroxide 5% / clindamycin1% / niacinamide 2% / tretinoin 0.025% gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 g
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 g
    TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN0.025 g  in 100 g
    CLINDAMYCIN PHOSPHATE (UNII: EH6D7113I8) (CLINDAMYCIN - UNII:3U02EL437C) CLINDAMYCIN PHOSPHATE1 g  in 100 g
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-1020-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2019
    Labeler - Sincerus Florida, LLC (080105003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sincerus Florida, LLC080105003manufacture(72934-1020)