IMIQUIMOD 5% / SALICYLIC ACID 30% / TRETINOIN 0.1% GEL [SINCERUS FLORIDA, LLC]

IMIQUIMOD 5% / SALICYLIC ACID 30% / TRETINOIN 0.1% GEL [SINCERUS FLORIDA, LLC]
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NDC 72934-1128-2
Set ID 883a24d3-e5fd-4329-e053-2995a90a9758
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Sincerus Florida, LLC
Generic Name
Product Class
Product Number
Application Number
  • Directions for use

    dw

  • Sincerus Florida. Adverse reactions

    fs

  • Active, inactive

    fw

  • NDC 72934-1128-2 IMIQUIMOD USP 5% / SALICILIC ACID USP 30%/ TRETINOIN USP 0.1%. Gel 30 gm.

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  • INGREDIENTS AND APPEARANCE
    IMIQUIMOD 5% / SALICYLIC ACID 30% / TRETINOIN 0.1% 
    imiquimod 5% / salicylic acid 30% / tretinoin 0.1% gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1128
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID30 g  in 100 g
    TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN0.1 g  in 100 g
    IMIQUIMOD (UNII: P1QW714R7M) (IMIQUIMOD - UNII:P1QW714R7M) IMIQUIMOD5 g  in 100 g
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-1128-230 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/07/2019
    Labeler - Sincerus Florida, LLC (080105003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sincerus Florida, LLC080105003manufacture(72934-1128)

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