Label: ANTIBACTERIAL HAND WIPES- hand sanitizer 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 August 14, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.13% w/w. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.



    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.



    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply to hands, allow to dry without wiping.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
    • May discolor fabrics
  • Inactive ingredients

    Disodium EDTA, Phenoxyethanol, Polysorbate 20, Sodium Hydroxide, Water.

  • Package Label - Principal Display Panel

    15 Wipes in 1 BAG NDC: 78870-002-01 Package Label

  • Package Label - Principal Display Panel

    40 Wipes in 1 BAG NDC: 78870-002-02 Package Label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES 
    hand sanitizer cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78870-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.5 g  in 100 g
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.001 g  in 100 g
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.05 g  in 100 g
    WATER (UNII: 059QF0KO0R) 99.269 g  in 100 g
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.05 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78870-002-0170 g in 1 BAG; Type 0: Not a Combination Product08/14/2020
    2NDC:78870-002-02185 g in 1 BAG; Type 0: Not a Combination Product08/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/14/2020
    Labeler - American Exchange Time Llc (830332164)
    Registrant - American Exchange Time Llc (830332164)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Jiayan Daily Commodity Co., Ltd.679832147manufacture(78870-002)
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