FLAWLESS FACE- 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 TREATMENT

Uses:

  • ​FOR THE TREATMENT OF ACNE
  • HELPS PREVENT NEW ACNE BLEMISHES

Warning:

For external use only

When Using This Product

  • KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
  • USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Stop use and ask a doctor if

  • rash occurs.

KEEP OUT OF REACH OF CHILDREN.

Directions:

  • CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICTION.
    COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY. BEACAUSE EXCESSIVE DRYING OF SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.

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)

Flawless Face Powder 1-SA_BKFlawless Face Powder 1-SA_FR

Flawless Face Powder 1-SA_LBL

FLAWLESS FACE 
salicylic acid powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-207
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:76354-207-511 in 1 BOX01/27/201512/31/2017
1NDC:76354-207-115 g in 1 TRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/27/201512/31/2017
Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 1/2015
 
J. A. Cosmetics U.S. INC