Label: CLARIFYING PRESSED POWDER- salicylic acid powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 19, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient:

    SALICYLC ACID 1%

  • PURPOSE

    Purpose:

    ACNE TRATMENT

  • INDICATIONS & USAGE

    Uses:

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

  • WARNINGS

    Warning:

    For external use only

  • WHEN USING

    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.
  • ASK DOCTOR

    Stop use and ask a doctor if

    • rash occurs.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DOSAGE & ADMINISTRATION

    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

    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)

  • PRINCIPAL DISPLAY PANEL

    Clarifying pressed powder_Back

    Clarifying pressed powder_Bottom

    Clarifying pressed powder_Front

  • INGREDIENTS AND APPEARANCE
    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)
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