CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17%- cimetidine 5% / ibuprofen 2% / salicylic acid 17% gel 
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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CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17%

Directions for use

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Sincerus Florida, LLC. Adverse reactions

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Active, inactive

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NDC 72934- 1047-2 CIMETIDINE USP 5% / IBUPROFEN USP 2% / SALICYLIC ACID USP 17%. Gel 30gm.

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CIMETIDINE 5% / IBUPROFEN 2% / SALICYLIC ACID 17% 
cimetidine 5% / ibuprofen 2% / salicylic acid 17% gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-1047
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN2 g  in 100 g
CIMETIDINE (UNII: 80061L1WGD) (CIMETIDINE - UNII:80061L1WGD) CIMETIDINE5 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID17 g  in 100 g
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-1047-230 g in 1 BOTTLE, PUMP; 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(72934-1047)

Revised: 5/2019
Document Id: 891a69a7-e005-c8c5-e053-2995a90ab49e
Set id: 891a69a7-e004-c8c5-e053-2995a90ab49e
Version: 1
Effective Time: 20190517
 
Sincerus Florida, LLC