Label: IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / NIACINAMIDE 2% 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

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  • Sincerus Florida, LLC adverse reactions.

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  • Active, Inactive

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  • NDC 72934-1125-2 IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / NIACINAMIDE 2%, Gel 30gm

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  • INGREDIENTS AND APPEARANCE
    IMIQUIMOD 5% / LEVOCETIRIZINE DIHYDROCHLORIDE 1% / NIACINAMIDE 2% 
    imiquimod 5% / levocetirizine dihydrochloride 1% / niacinamide 2% gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IMIQUIMOD (UNII: P1QW714R7M) (IMIQUIMOD - UNII:P1QW714R7M) IMIQUIMOD5 g  in 100 g
    LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O) LEVOCETIRIZINE DIHYDROCHLORIDE1 g  in 100 g
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-1125-230 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(72934-1125)