Label: AWAKEN OIL-FREE 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 September 18, 2014

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  • Active ingredient

    Salicylic Acid 2.0%

  • Purpose

    Acne Treatment

  • Indications

    •
    for the treatment of acne
  • Warnings

    For external use only.

    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.

    When using this product avoid contact with the eyes. If product gets into eyes, rinse thoroughly with water.

  • Keep Out of Reach of Children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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.
  • Other Information

     
    Oil-Free Daily Face Wash is a rich cream cleanser enriched with moisturizing ingredients to help restore moisture while washing away dirt, oil and bacteria, leaving skin softer and clearer.
  • Inactive ingredients

    water, glycerin, sodium lauroyl sarcosinate, stearic acid, potassium hydroxide, myristic acid, lauric acid, palmitic acid, fragrance, phenoxyethanol, ethylhexylglycerin, polyquaternium-10, disodium EDTA, methylparaben, ethylparaben, butylparaben, propylparaben, isobutylparaben, aloe barbadensis leaf juice, sodium benzoate, potassium sorbate, menthol.

  • Package/Label Principal Display Panel Awaken by Quality Choice® oil-free daily face wash Acne Fighting Medication Salicylic acid Fewer breakouts in just 4 weeks Non-drying *Compare to Clearasil Ultra® Daily Face Wash ingredients Net Wt 6.5 Fl Oz (184 mL) Distributed by C.D.M.A., Inc.® 43157 W. Nine MileNovi, MI 48376-0995 Questions: 248-449-9300*This product is not manufactured or distributed by Reckitt Benckiser owner of the registered trademark Clearasil Daily Clear®.Manufactured in Israel0D48A CD T1

    Carton Lable

    Carton Label

  • INGREDIENTS AND APPEARANCE
    AWAKEN OIL-FREE DAILY FACE WASH 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-249
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-249-07184 mL 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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