Label: EZPHARM HAND SANITIZING TISSUE- benzalkonium liquid

  • 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 July 4, 2020

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  • ACTIVE INGREDIENT

    benzalkonium

  • INACTIVE INGREDIENT

    Water, Glycerin, Polysorbate 80, Sodium Benzonate, Citric Acid, Maltodextrin, Aloe Barbadensis Leaf Juice Powder, Fragrance, Tocopheryl Acetate

  • PURPOSE

    ■ To decrease bacteria on the skin that could cause disease

    ■ Recommended for repeated use

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    ■ Wipe hands thoroughly with product and allow to dry.

    ■ Discard wipe in trash. Do not flush.

  • WARNINGS

    ■ keep out of eyes. In case of contact with eyes, flush thoroughly with water.

    ■ avoid contact with broken skin.

    ■ do not inhale or ingest.

  • DOSAGE & ADMINISTRATION

    external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    EZPHARM HAND SANITIZING TISSUE 
    benzalkonium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58474-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58474-001-0180 mL in 1 PACKAGE; Type 0: Not a Combination Product07/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/11/2020
    Labeler - WOOIL C&TECH.CORP (688331078)
    Registrant - WOOIL C&TECH.CORP (688331078)
    Establishment
    NameAddressID/FEIBusiness Operations
    WOOIL C&TECH.CORP688331078manufacture(58474-001)
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