Label: WIPE OUT ANTIBACTERIAL WIPES, LEMON SCENT- benzalkonium chloride cloth

  • NDC Code(s): 34645-0009-1, 34645-0009-2
  • Packager: Jianerkang Medical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Uses

    To decrease bacteria on the skin that could cause disease

  • Warnings

    • For external use only

    When using this product

    • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin

    Stop use and ask a doctor if

    • irritation and redness develops
    • condition persists 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

    • allow to dry without wiping
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Other Information

    • keep containers tightly closed in a dry, cool and well-ventilated place.
    • recommended storage temperature: 32°F to 104°F (0°C to 40°C)
  • Inactive Ingredients

    aloe barbadensis leaf juice, fragrance, phenoxyethanol, polysorbate 20, propylene glycol, tocopheryl acetate, water

  • Package Labeling:20c

    Bottle2

  • Package Labeling:80c

    Bottle3

  • INGREDIENTS AND APPEARANCE
    WIPE OUT ANTIBACTERIAL WIPES, LEMON SCENT 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-0009
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-0009-120 in 1 BAG09/16/2020
    14.2 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:34645-0009-280 in 1 BOTTLE09/16/2020
    23.525 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)09/16/2020
    Labeler - Jianerkang Medical Co., Ltd (530968767)
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