Label: DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5%- dapsone 8.5% / niacinamide 2% / spironolactone 5% 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 May 9, 2019

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  • Directions for use
  • Sincerus Florida, LLC. Adverse reactions
  • Active, inactive
  • NDC 72934-1064-2 DAPSONE USP 8.5% / NIACINAMIDE USP 2% / SPIRONOLACTONE USP 5%. Gel 30gm
  • INGREDIENTS AND APPEARANCE
    DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5% 
    dapsone 8.5% / niacinamide 2% / spironolactone 5% gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72934-1064
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232) SPIRONOLACTONE 5 g  in 100 g
    DAPSONE (UNII: 8W5C518302) (DAPSONE - UNII:8W5C518302) DAPSONE 8.5 g  in 100 g
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g  in 100 g
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72934-1064-2 30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/10/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/10/2019
    Labeler - Sincerus Florida, LLC (080105003)
    Establishment
    Name Address ID/FEI Business Operations
    Sincerus Florida, LLC 080105003 manufacture(72934-1064)
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