Label: ANTIBACTERIAL HAND WIPES VITAMIN C- 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 October 27, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.1%

    Purpose

    Antiseptic

  • Use

    Antiseptic Cleanser, helps decrease bacteria on skin.

  • Warnings

    For external use only.

    When using this product

    Avoid contact with the eyes; in case of contact, flush eyes with water

    Stop use and ask a doctor if

    irritation or redness develops and persists.

    Keep out of reach of children.

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

  • Directions

    • Lift tab and poull out towel to wipe hands thoroughly for 30 seconds. Allow to air dry.
    • Reseal after use to prevent moisture from evaporating.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • store at room temperature.
  • Inactive ingredients

    Water (Aqua), Polysorbate 20, Ascorbic Acid (Vitamin C), Disodium EDTA, Phenoxyethanol, Sodium Hydroxide.

  • Label copy

    image of the label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES  VITAMIN C
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78936-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78936-022-0175 in 1 CANISTER; Type 0: Not a Combination Product10/26/2020
    2NDC:78936-022-0225 in 1 PACKAGE; Type 0: Not a Combination Product10/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/26/2020
    Labeler - Hangzhou Caring Cleaning Commodity Co., LTD. (413905445)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Caring Cleaning Commodity Co., LTD.413905445manufacture(78936-022)
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