KETOCONAZOLE 2% / SALICYLIC ACID 2%- ketoconazole 2% / salicylic acid 2% shampoo 
Sincerus Florida, LLC

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.

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KETOCONAZOLE 2% / SALICYLIC ACID 2%

Directions for use

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Sincerus Florida, LLC. Adverse reactions

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Active, inactive

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NDC 72934- 7133-6 KETOCONAZOLE USP 2% / SALICYLIC ACID USP 2%. Shampoo 120gm.

SF

KETOCONAZOLE 2% / SALICYLIC ACID 2% 
ketoconazole 2% / salicylic acid 2% shampoo
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-7133
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE2 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-7133-6120 g in 1 CYLINDER; Type 0: Not a Combination Product05/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/17/2019
Labeler - Sincerus Florida, LLC (080105003)
Establishment
NameAddressID/FEIBusiness Operations
Sincerus Florida, LLC080105003manufacture(72934-7133)

Revised: 5/2019
Document Id: 89062fdd-eed3-022a-e053-2995a90a53da
Set id: 89062fdd-eed2-022a-e053-2995a90a53da
Version: 1
Effective Time: 20190516
 
Sincerus Florida, LLC