SALICYLIC ACID 5% / SODIUM SULFACETAMIDE MONOHYDRATE 10%- salicylic acid 5% / sodium sulfacetamide monohydrate 10% suspension 
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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SALICYLIC ACID 5% / SODIUM SULFACETAMIDE MONOHYDRATE 10%

Directions for use

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Sincerus Florida, LLC. Adverse reactions

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Active, inactive

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NDC 72934- 8172-6 SALICYLIC ACID USP 5% / SODIUM SULFACETAMIDE MONOHYDRATE USP 10%. Suspension 120 gm

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SALICYLIC ACID 5% / SODIUM SULFACETAMIDE MONOHYDRATE 10% 
salicylic acid 5% / sodium sulfacetamide monohydrate 10% suspension
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72934-8172
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 g  in 100 g
SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM10 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72934-8172-6120 g in 1 BOTTLE, PLASTIC; 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(72934-8172)

Revised: 5/2019
Document Id: 8904583c-311e-12af-e053-2995a90a7e41
Set id: 8904583c-311d-12af-e053-2995a90a7e41
Version: 1
Effective Time: 20190516
 
Sincerus Florida, LLC