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

Drug Label Information

Updated June 11, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!