FLAWLESS FACE by J. A. Cosmetics U.S. INC / Shanghai J. A. Cosmetics Trading CO., LTD.

FLAWLESS FACE by

Drug Labeling and Warnings

FLAWLESS FACE by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 
salicylic acid powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-207-51	1 in 1 BOX	01/27/2015	12/31/2017
1	NDC: 76354-207-11	5 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/27/2015	12/31/2017

Labeler - J. A. Cosmetics U.S. INC (186705047)

Revised: 1/2015

Document Id: f4780fca-e604-4186-9cae-e8b27e859b7d

34390-5

Set id: 571ba386-7551-4e51-99d6-151cad2d82dd

Version: 2

Effective Time: 20150127

 

J. A. Cosmetics U.S. INC