Label: AWAKEN BY QUALITY CHOICE ULTRA CLEAN DAILY FACE WASH- salicylic acid cream

  • 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 October 1, 2014

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  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Acne medication

  • Indications

    •
    for the treatment of acne
  • Warnings

    For external use only.

    When using this product

    •
    Avoid contact with the eyes. If product gets into eyes, rinse thoroughly with water.
    •
    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.
  • Keep Out of Reach of Children.

    If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes If contact occurs flush thoroughly with water.

  • Directions

    •
    Wet face.
    •
    Dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area.
    •
    Rinse thoroughly with warm water and pat dry.
    •
    For best results, use twice a day.
  • Inactive ingredients

    water, sodium cocoyl isethionate, cetearyl alcohol, stearic acid, sodium hydroxide, glycerin, laureth-3, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, fragrance, DMDM hydantoin, caramel, disodium EDTA, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract.

  • Package/Label Principal Display Panel

    Awaken
    by Quality Choice

    ultra clean
    daily face wash

    ACNE FIGHTING
    MEDICATION

    2% salicylic acid

    *Compare to Clearasil Ultra
    Daily FaceWash ingredients

    NET WT 6.78 FL OZ (200 mL)

    Ultra Clean Daily Face Wash with salicylic acid fights the causes of acne to give visibly clearer skin. This creamy face wash instantly starts working to fight acne 100% by washing away pimple-causing bacteria.

    *This product is not manufactured or distributed by Reckitt Benckiser, owner of the registered trademark Clearasil Ultra®

    Distributed by C.D.M.A., Inc.©
    43157 W. Nine Mile
    Novi, MI 48376-0995
    www.qualitychoice.com
    Questions: 248-449-9300

    SATISFACTION GUARANTEED

    Manufactured in Israel
    0D34D CD T1

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    AWAKEN BY QUALITY CHOICE ULTRA CLEAN DAILY FACE WASH 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURETH-3 (UNII: F32E4CB0UJ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CARAMEL (UNII: T9D99G2B1R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAVANDULA STOECHAS FLOWERING TOP (UNII: 70759G2U6A)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    CISTUS MONSPELIENSIS LEAF (UNII: 1IE70KNO43)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-250-071 in 1 CARTON
    1200 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/01/2014
    Labeler - Chain Drug Marketing Association (011920774)
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