Label: ACNE CLEANSER AWAKEN BY QUALITY CHOICE- salicylic acid 2.00% 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 January 9, 2018

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  • ACTIVE INGREDIENT

    Active ingredient                                                                     Purpose
    Salicylic Acid 2%......................................................................Acne Treatment

  • PURPOSE

  • Use

    for the treatment of acne

  • WarningsFor external use only.


    Allergy alert: Do not use this product if you have a known allergy to salicylic acid
    When using this product • skin irritation and dryness is more likely to occur
    if you use another topical acne medication at the same time. If irritation
    occurs, only use one topical acne medication at a time. • 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

  • Directions

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

  • Inactive ingredients

     Water, Sodium C14-16
    Olefin Sulfonate, Cocamidopropyl Betaine, Chamomilla
    Recutita (Matricaria) Flower Extract, Cocamidopropyl
    PG-Dimonium Chloride Phosphate, Propylene Glycol, Aloe
    Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract,
    C12-15 Alkyl Lactate, PEG-80 Sorbitan Laurate, Disodium
    EDTA, Benzalkonium Chloride, Fragrance, Yellow 5, Red

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    ACNE CLEANSER  AWAKEN BY QUALITY CHOICE
    salicylic acid 2.00% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-777
    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)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Cocamidopropyl PG-Dimonium Chloride Phosphate (UNII: H2KVQ74JM4)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    ALOE (UNII: V5VD430YW9)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    C12-15 Alkyl Lactate (UNII: GC844VRD7E)  
    PEG-80 Sorbitan Laurate (UNII: 239B50Y732)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-777-05177 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/13/2014
    Labeler - Quality Choice (011920774)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(63868-777) , label(63868-777)
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