CLARIFYING PRESSED POWDER- salicylic acid powder 
J. A. Cosmetics U.S. INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient:

SALICYLC ACID 1%

Purpose:

ACNE TRATMENT

Uses:

Warning:

For external use only

When Using This Product

Stop use and ask a doctor if

KEEP OUT OF REACH OF CHILDREN.

Directions:

Inactive Ingredient:

TALC, MICA, MAGNESIUM STEARATE, ETHYLHEXYL PALMITATE, PARAFFINUM LIQUIDUM (MINERAL OIL), POLYBUTENE, SODIUM DEHYDROACETATE, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE (PARFUM)

May Contain: TITANUM DIOXIDE (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

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CLARIFYING PRESSED POWDER 
salicylic acid powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
MICA (UNII: V8A1AW0880)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76354-201-511 in 1 BOX
1NDC:76354-201-1130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/10/2013
Labeler - J. A. Cosmetics U.S. INC (186705047)
Registrant - J. A. Cosmetics U.S. INC (186705047)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai J. A. Cosmetics Trading CO., LTD.421280183manufacture(76354-201)

Revised: 3/2014
Document Id: fdba8c12-9186-4605-9cbc-216a4a1f176f
Set id: a75a4012-2c6c-4bc1-95f0-ec5713314762
Version: 3
Effective Time: 20140319
 
J. A. Cosmetics U.S. INC