Label: FLUOCINOLONE ACETONIDE 0.01% / MINOXIDIL 7% / PROGESTERONE 0.1% solution

  • 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 May 8, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Directions for use

    zc

  • Sincerus Florida, LLC. Adverse reactions

    xc

  • Active, inactive

    sd

  • NDC 72934-4080-8. FLUOCINOLONE ACETONIDE USP 0.01% / MINOXIDIL USP 7% / PROGESTERONE USP 0.1%. Solution 60 gm.

    zx

  • INGREDIENTS AND APPEARANCE
    FLUOCINOLONE ACETONIDE 0.01% / MINOXIDIL 7% / PROGESTERONE 0.1% 
    fluocinolone acetonide 0.01% / minoxidil 7% / progesterone 0.1% solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-4080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M) FLUOCINOLONE ACETONIDE0.01 g  in 100 g
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL7 g  in 100 g
    PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE0.1 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72934-4080-860 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/09/2019
    Labeler - Sincerus florida, LLC (080105003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sincerus Florida, LLC080105003manufacture(72934-4080)