Label: THERAPLUS ANTIBACTERIAL WIPES FRESH SCENT WITH ALOE AND VITAMIN E- benzalkonium chloride cloth

  • NDC Code(s): 80684-007-20
  • Packager: Fourstar Group USA, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.1%

    Purpose

    Antibacterial

  • Use

    decreases bacteria on skin

  • Warnings

    For external use only.

    Do not use

    • over large areas of the body
    • if you are allergic to any of the ingredients

    When using this product

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

    Stop use and ask a doctor if

    irritation or rash develops and continues for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    • for adults and children of 2 years and over
    • children under 2 year ask a doctor before use
    • allow to dry without wiping
  • Other information

    store at room temperature

  • Inactive ingredients

    Water, Glycerin, Phenoxyethanol, Polysorbate 20, Aloe Barbadensis Leaf Extract, Polyaminopropyl Biguanide, Disodium EDTA, Fragrance, 2-Bromo-2-Nitropropane-1,3-Diol, Tocopheryl Acetate

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    THERAPLUS ANTIBACTERIAL WIPES FRESH SCENT WITH ALOE AND VITAMIN E 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80684-007-2020 in 1 BAG11/10/2020
    13.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/10/2020
    Labeler - Fourstar Group USA, Inc. (140099503)
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