Label: OIL FREE ACNE SCRUB SALICYLIC ACID ACNE TREATMENT- salicylic acid liquid

  • 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 July 8, 2010

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  • ACTIVE INGREDIENT


    Drug Facts
    Active Ingredient   Salicylic Acid 2%
    Purpose  Acne Treatment

    Use for the treatment of acne


  • WARNINGS

    Warnings

    For external use only

    Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product.  This may increase dryness or irritation of the skin.  If this occurs, only one medication should be used unless directed by a doctor.

    When using this product avoid contact with eyes.  If contact occurs, flush thoroughly with water.

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




  • INFORMATION FOR PATIENTS



    Directions   Cleanse twice a day.  Wet face.  Apply to hands, add water and work into a lather.  Massage face gently.  Rinse thoroughly.
  • INACTIVE INGREDIENT

    Inactive Ingredients  Water, Glycerin, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Polyethylene, Acrylates Copolymer, Vistis Vinifera (Grape) Seed Extract, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Citrus Grandis (Grapefruit) Fruit Extract, Polyquaternium-7, Camellia Sinensis Leaf Extract, Ascorbyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Anthemis Nobilis Flower Extract, Benzalkonium Chloride, Sodium Benzotriazolyl Butylphenol Sulfonate, Buteth-3, Tributyl Citrate, PEG-12 Methyl Glucose Dioleate, Sodium Citrate, Disodium EDTA, Agar, Mica, Titanium Dioxide, Sodium Hydroxide, Red 30 Lake, Red 40, Ext. Violet 2, Fragrance

  • PRINCIPAL DISPLAY PANEL

    4 oz scrub label
  • INGREDIENTS AND APPEARANCE
    OIL FREE ACNE SCRUB  SALICYLIC ACID ACNE TREATMENT
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57501-953
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid2.5 g  in 125 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Ethylene (UNII: 91GW059KN7)  
    Acrylic Acid (UNII: J94PBK7X8S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57501-953-04125 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/08/2010
    Labeler - Apex International Mfg (015226132)
    Registrant - Apex International Mfg (015226132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apex International Mfg015226132manufacture
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