Label: B PURE BLEMISH CONCEALER FOR ACNE PRONE SKIN FAIR- salicylic acid cream

  • NDC Code(s): 80684-109-00
  • Packager: Fourstar Group USA, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 11, 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.

    Stop use and ask a doctor if

    • rectal bleeding occurs.
    • condition worsens or does not improve within 7 days.

    Keep out of reach of children.

  • Directions

    • apply to clean skin.
    • apply to the temples, brows bones, cheekbones, and affected areas.
    • blend with your fingers for a clean, sculpted look.
  • Other information

    Store at room temperature.

  • Inactive ingredients

    water, isododecane, ethylhexyl palmitate, propylene glycol, glycerin, lauryl dimethicone, polyglyceryl-2 diisostearate, c12-15 alkyl benzoate, hydrogenated polyisobutene, microcrystalline wax, quaternium-18 bentonite, peg-10 dimethicone, peg-30 dipolyhydroxystearate, magnesium stearate, magnesium sulfate, phenoxyethanol, chlorphenesin, ethylhexylglycerin, tocopheryl acetate, disodium edta, titanium dioxide, iron oxides

  • Questions?

    1-800-639-3803 Weekdays 9 AM to 4 PM EST

    Call toll-free 508-473-7688 or visit www.foustari.com

  • Package Labeling:

    Label02

  • INGREDIENTS AND APPEARANCE
    B PURE BLEMISH CONCEALER FOR ACNE PRONE SKIN FAIR 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-109
    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
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-2 DIISOSTEARATE (UNII: DG195GP57P)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    BENTOQUATAM (UNII: 7F465U79Q1)  
    PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80684-109-001.4 g in 1 TUBE; 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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