Label: INSTANT HAND SANITIZER WIPES- benzalkonium chloride cloth

  • 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 September 30, 2015

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  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Citric Acid, Fragrance, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Polysorbate 20, Tocopheryl Acetate, Water

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Principal Display Panel

    image description

  • Purpose

    Antimicrobial

  • DOSAGE & ADMINISTRATION

  • Directions

    • To open or close package see illustrations on the left
    • remove wipe
    • wipe hands thoroughly for 30 seconds
    • discard in trash, do not flush
  • Warnings

    For External Use Only

    When using this product avoid contact with eyes,

    Stop use and ask a doctor

    • if irritation or redness develop
    • if conditions persists for more than 72 hours
  • Keep out of reach of children

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

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-665
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.13 mg  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 mg  in 100 mL
    CITRIC ACID ACETATE (UNII: DSO12WL7AU) 1 mg  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1 mg  in 100 mL
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) 1 mg  in 100 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 1 mg  in 100 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 1 mg  in 100 mL
    WATER (UNII: 059QF0KO0R) 1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-665-20110 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/02/2015
    Labeler - CVS (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes International, Inc.161104729manufacture(59779-665)