Label: IMIQUIMOD 5% / NIACINAMIDE 4% gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72934-1127-2 - Packager: Sincerus Florida, LLC
- 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 6, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Directions for use
- Sincerus Florida. Adverse reactions
- Active, inactive
- NDC 72934-1127-2 IMIQUIMOD USP 5% / NIACINAMIDE USP 4%. Gel 30 gm
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INGREDIENTS AND APPEARANCE
IMIQUIMOD 5% / NIACINAMIDE 4%
imiquimod 5% / niacinamide 4% gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72934-1127 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 4 g in 100 g IMIQUIMOD (UNII: P1QW714R7M) (IMIQUIMOD - UNII:P1QW714R7M) IMIQUIMOD 5 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:72934-1127-2 30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/07/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/07/2019 Labeler - Sincerus Florida, LLC (080105003) Establishment Name Address ID/FEI Business Operations Sincerus Florida, LLC 080105003 manufacture(72934-1127)
