Label: AWAKEN BY QUALITY CHOICE FOAMING HAND WASH SPRING SHOWERS- benzalkonium chloride soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 22, 2016

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  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Uses

    helps eliminate bacterial on hands.

  • Warnings

    For external use only.

    When using this product

    avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    irritation or redness develops and lasts.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    Pump onto dry hands. Work into a rich foamy lather, rinse thoroughly and dry.

  • Other information

    Store at room temperature.

  • Inactive ingredients

    Water (Aqua), Cocamidopropyl Betaine, Glycerin, Decyl Glucoside, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Fragrance (Parfum), Polyquaternium-7, Xanthan Gum, Tetrasodium EDTA, Polysorbate 20, Sodium Citrate, Propylene Glycol, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Blue1 (CI 42090), Ext. Violet 2 (CI 60730).

  • Questions or comments?

    1-248-449-9300

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    AWAKEN BY QUALITY CHOICE FOAMING HAND WASH  SPRING SHOWERS
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-115-07222 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/18/2016
    Labeler - Chain Drug MArketing Association Inc (011920774)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(63868-115)
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