Label: NIACINAMIDE 4% / 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 April 23, 2019

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  • Directions for use

    Directions for use. As directed by Physician. Apply topically. For external use only. Wash hands after use. Store at controlled room temperature 20-25 Celsius.

  • Sincerus Florida, LLC adverse reactions

    ABC

  • Active Inactive

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  • NDC 72934-1162-2 NIACINAMIDE 4% / TRETINOIN 0.025%

    NDC 72934-1162-2 NIACINAMIDE 4 / TRETINOIN 0.025 Cream 30gm Sincerus Florida This is a compound drug Made in USA

  • INGREDIENTS AND APPEARANCE
    NIACINAMIDE 4% / TRETINOIN 0.025% 
    niacinamide 4% / tretinoin 0.025% gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1162
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN0.025 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:72934-1162-230 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(72934-1162)