Label: 011218 NIACINAMIDE 2% / SPIRONOLACTONE 5% / 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 July 2, 2020

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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 72934-1206-2 011218 NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.025% gel 30 gm

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  • INGREDIENTS AND APPEARANCE
    011218 NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.025% 
    011218 niacinamide 2% / spironolactone 5% / tretinoin 0.025% gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 g
    SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232) SPIRONOLACTONE5 g  in 100 g
    TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN0.025 g  in 100 g
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-1206-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/02/2020
    Labeler - Sincerus Florida, LLC (080105003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sincerus Florida, LLC080105003api manufacture(72934-1206)