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.

----------

Active Ingredient:

SALICYLC ACID 1%

Purpose:

ACNE TRATMENT

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:

  • CLEANSETHE 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)

Clarifying pressed powder_Back

Clarifying pressed powder_Bottom

Clarifying pressed powder_Front

CLARIFYING PRESSED POWDER 
salicylic acid powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76354-201
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
MAGNESIUM STEARATE 
ETHYLHEXYL PALMITATE 
MINERAL OIL 
POLYBUTENE (1400 MW) 
SODIUM DEHYDROACETATE 
METHYLPARABEN 
PROPYLPARABEN 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
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: 2/2014
 
J. A. Cosmetics U.S. INC