Label: IMIQUIMOD 5% / SALICYLIC ACID 30% / TRETINOIN 0.1% gel
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Contains inactivated NDC Code(s)
NDC Code(s): 72934-1128-2 - Packager: Sincerus Florida, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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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 72934-1128-2 IMIQUIMOD USP 5% / SALICILIC ACID USP 30%/ TRETINOIN USP 0.1%. Gel 30 gm.
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INGREDIENTS AND APPEARANCE
IMIQUIMOD 5% / SALICYLIC ACID 30% / TRETINOIN 0.1%
imiquimod 5% / salicylic acid 30% / tretinoin 0.1% gelProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72934-1128 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 30 g in 100 g TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R) TRETINOIN 0.1 g in 100 g IMIQUIMOD (UNII: P1QW714R7M) (IMIQUIMOD - UNII:P1QW714R7M) IMIQUIMOD 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:72934-1128-2 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(72934-1128)
