Label: AF FOAM SENSITIVE ACNE PORE CLEANSER- salicylic acid aerosol, foam

  • 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 December 14, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: Salicylic Acid 1.5% w/v
  • PURPOSE

    Purpose: Acne Treatment
  • INDICATIONS & USAGE

    Use for the treatment of acne.
  • WARNINGS

    Warnings: For external use only
  • DO NOT USE

    Do not use If you have a known allergy to Salicylic Acid or aspirin.
    Using other topical acne medications at the same time or right after use of this product may increase drynes or irritation of the skin. If this occurs only one medication should be used unless directed by a doctor.
  • WHEN USING

    When using this product
    • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. If you have aspirin sensitivity, consult a physician prior to use.
  • STOP USE

    Stop use and ask a doctor if excessive irritation occurs.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    • Use AM and PM. Recommended: after AM use, follow with AcneFree All-Day Acne Control. After PM use, follow with AcneFree 3-in-1 Acne Night Repair.
    • Moisten skin.
    • Shake can before use.
    • Press down firmly on dispenser and apply a small amount of foam (not more than a dollop the size of golf ball) into hand.
    • Using fingers, apply to face and gently massage to cleanse.
    • Rinse thoroughly with warm water and pat dry.
    • If bothersome peeling occurs, reduce application use.
    • If going outside, use a sunscreen.
  • STORAGE AND HANDLING

    Other information
    • Store at 60o- 85o F (15o-30o C).
    • Pressurized container: Protect from sunlight and do not expose to temperatures exceeding 120oF
      (49o C). Do not puncture or burn, even after use. Use only as directed.
  • INACTIVE INGREDIENT

    Inactive ingredients: Avena Sativa (Oat) Kernel Extract, Bisabolol, Cocamidopropyl Betaine, Disodium Laureth Sulfosuccinate, Glycerin, Methylisothiazolinone, Phenoxyethanol, Sodium Chloride, Sodium Hydroxide, Sodium C14-16 Olefin Sulfonate, Tetrasodium Glutamate Diacetate, Water/Aqua/Eau, Zinc PCA, Zingiber Officinale (Ginger) Root Extact.
  • PRINCIPAL DISPLAY PANEL

    AcneFree Sensitive

    Gentle Formula
    Acne Pore Cleanser
    Salicylic Acid 1.5%

    Rinse-Off Foam
    Medicine Stays In Pores Even After Rinsing
    Front Label
    Drug Facts 1
    Drug Facts 2
  • INGREDIENTS AND APPEARANCE
    AF FOAM SENSITIVE ACNE PORE CLEANSER 
    salicylic acid aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    salicylic acid (UNII: O414PZ4LPZ) (Salicylic acid - UNII:O414PZ4LPZ) salicylic acid1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    oat (UNII: Z6J799EAJK)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    glycerin (UNII: PDC6A3C0OX)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    water (UNII: 059QF0KO0R)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    ginger (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50544-304-4085 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/15/2011
    Labeler - University Medical Pharmaceuticals Corp (809706252)
    Registrant - University Medical Pharmaceuticals Corp (809706252)
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