NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.05% GEL [SINCERUS FLORIDA LLC]

NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.05% GEL [SINCERUS FLORIDA LLC]
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NDC 72934-1153-2
Set ID 87ed3aff-1a10-c070-e053-2a95a90af490
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Sincerus Florida LLC
Generic Name
Product Class Aldosterone Antagonist
Product Number
Application Number
  • Directions for use.
  • Sincerus Florida, LLC adverse reactions.
  • Active, inactive
  • NDC 72934-1153 NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.05% Gel 30 gm.
  • INGREDIENTS AND APPEARANCE
    NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.05% 
    niacinamide 2% / spironolactone 5% / tretinoin 0.05% gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72934-1153
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g  in 100 g
    TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN 0.05 g  in 100 g
    SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232) SPIRONOLACTONE 5 g  in 100 g
    Product Characteristics
    Color yellow Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:72934-1153-2 30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/03/2019
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/03/2019
    Labeler - Sincerus Florida LLC (080105003)
    Establishment
    Name Address ID/FEI Business Operations
    Sincerus Florida LLC 080105003 manufacture(72934-1153)
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