Label: B PURE PRESSED POWDER FOR ACNE PRONE SKIN FAIR- salicylic acid powder

  • NDC Code(s): 80684-110-00
  • Packager: Fourstar Group USA, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 17, 2024

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  • Drug Facts

  • Active ingredient

    Salicylic Acid 0.5%

    Purpose

    Acne medication

  • Uses

    For the treatment of acne.

  • Warnings

    For external use only.

    When using this product

    • If using other topical acne medicines, dryness and skin irritation can occur.
    • Discontinue use if irritation occurs.
    • Do not use this product around the eye area.

    Keep out of reach of children.

  • Directions

    • Apply all over your face using a makeup brush, avoiding the eye area
    • Start from the center and move to the outer portion of the face.
  • Other information

    Store at room temperature.

  • Inactive ingredients

    mica, magnesium stearate, silica, aluminum starch octenylsuccinate, ethylhexyl palmitate, hydrogenated polyisobutene, isononyl isononanoate, tridecyl trimellitate, bis-diglyceryl polyacyladipate-2, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, tocopheryl acetate, zinc oxide, iron oxides

  • Questions?

    1-800-639-3803

    Weekdays 9 AM to 4 PM EST

  • Package Labelling:

    Outer Package.jpg

  • INGREDIENTS AND APPEARANCE
    B PURE PRESSED POWDER FOR ACNE PRONE SKIN FAIR 
    salicylic acid powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80684-110-004.8 g in 1 CONTAINER; Type 0: Not a Combination Product09/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/01/2024
    Labeler - Fourstar Group USA, Inc. (140099503)
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