Label: OIL FREE DAILY FACE WASH AWAKEN BY QUALITY CHOICE- 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 June 7, 2018

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  • ACTIVE INGREDIENT

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

  • PURPOSE

  • INDICATIONS & USAGE

    Use For the treatment of acne.

  • WarningsFor external use only.

    When using this product • skin irritation and dryness are 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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    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
    Acrylates/C10-30 Alkyl Acrylate Crosspolymer
    Cetearyl Alcohol
    Cistus Monspeliensis Extract
    Disodium EDTA
    Fragrance
    Glycerin
    Helichrysum Italicum Extract
    Lavandula Stoechas Extract
    Sodium Cocamidopropyl Betaine
    Sodium Cocoyl Isethionate
    Sodium Hydroxide
    Sodium Laureth Sulfate
    Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    OIL FREE DAILY FACE WASH  AWAKEN BY QUALITY CHOICE
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-780
    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 Cocoyl Isethionate (UNII: 518XTE8493)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAVANDULA STOECHAS FLOWERING TOP (UNII: 70759G2U6A)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-780-05201 mL in 1 TUBE; Type 0: Not a Combination Product09/26/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D09/26/2016
    Labeler - Quality Choice (011920774)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(63868-780) , label(63868-780)
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