Label: DAILY CARE FOAMING CLEANSER 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 March 20, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Acne treatment gel

  • Uses

    • for the treatment of acne
    • dries up acne pimples
    • helps prevent new acne pimples
  • Warnings

    For external use only

    When using this product

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

    Stop use and ask a doctor if

    • irritation becomes severe

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

  • Directions

    • use AM and PM
    • wet face
    • gently massage product all over face for 20-30 seconds avoiding eye area
    • rinse thoroughly and pat dry
    • wait 10-15 minutes to allow skin to dry completely
  • Other information

    • store away from heat and direct sunlight
    • store at controlled room temperature: 15°C–25°C (59°F–77°F)
  • Inactive ingredients

    butyl avocadate, cetyl hydroxyethylcellulose, cocamidopropyl betaine, disodium EDTA, ethoxydiglycol, Ext. Violet 2 (CI 60730), fragrance, menthol, menthyl lactate, sodium laureth sulfate, sodium lauryl sulfate, water (aqua)

  • Questions or comments?

    1.800.636.7546

    Monday–Friday 9 a.m.–4 p.m. Pacific Time

  • SPL UNCLASSIFIED SECTION

    Distributed by OMP, Inc., Long Beach, CA 90806

  • PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

    FOR PROFESSIONAL USE ONLY

    OBAGI®
    MEDICAL

    Daily Care
    Foaming Cleanser

    Salicylic Acid 2%
    Acne Treatment

    Removes dirt and excess oil,
    leaving skin clean and refreshed

    33.8 fl. oz. (1 L)

    Principal Display Panel - 1 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    DAILY CARE FOAMING CLEANSER   ACNE TREATMENT
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL (UNII: L7T10EIP3A)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62032-129-071000 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/18/2013
    Labeler - OMP, INC. (790553353)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(62032-129)
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