Label: DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5% gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72934-1064-2 - Packager: Sincerus Florida, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
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Drug Label Information
Updated May 9, 2019
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- Official Label (Printer Friendly)
- 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
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INGREDIENTS AND APPEARANCE
DAPSONE 8.5% / NIACINAMIDE 2% / SPIRONOLACTONE 5%
dapsone 8.5% / niacinamide 2% / spironolactone 5% gelProduct 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)
