Label: CLINDAMYCIN 1% / NIACINAMIDE 4% / SPIRONOLACTONE 2% / TRETINOIN 0.025% gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 May 3, 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 72934-1052-2. CLINDAMYCIN PHOSPHATE USP 1%, NIACINAMIDE USP 4% / SPIRONOLACTONE USP 2% / TRETINOIN USP 0.025%. Gel30gm

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  • INGREDIENTS AND APPEARANCE
    CLINDAMYCIN 1% / NIACINAMIDE 4% / SPIRONOLACTONE 2% / TRETINOIN 0.025% 
    clindamycin 1% / niacinamide 4% / spironolactone 2% / tretinoin 0.025% gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232) SPIRONOLACTONE2 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
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE4 g  in 100 g
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-1052-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/04/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/04/2019
    Labeler - Sincerus Florida, LLC (080105003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sincerus Florida, LLC080105003manufacture(72934-1052)