Label: HAND SANITIZER WIPES- benzalkonium chloride gel

  • 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 March 6, 2018

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  • Active Ingredient

    benzalkonium chloride 0.13%

  • Purpose

    Antimicrobial

  • Use

    for hand sanitizing to decrease bacteria on the skin.

    recommended for repeated use

  • Warning

    For external use only

    when using this product,avoid contact with eyes,

    In case of contact flush eyes with water

    Stop use and ask a doctor if irritation or redness develop

    if swallowed get medical help or caontact a poison control center reght away.

    Keep out of reach of children

  • Directions

    take wipe and rub thoroughly over all surfaces of both hands.rub hands together briskly to dry ,dispose of wipe

  • INACTIVE INGREDIENT

    purified Water,Glycerin,Aloe Barbadensis Leaf Juice,nonionic surfactant

  • PRINCIPAL DISPLAY PANEL

    1

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  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER WIPES 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71766-001
    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
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71766-001-011000 in 1 CARTON10/10/2017
    11 in 1 PACKET
    10.016 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:71766-001-02120 in 1 CARTON10/10/2017
    210 in 1 PACKET
    20.016 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:71766-001-03120 in 1 CARTON10/10/2017
    315 in 1 PACKET
    30.024 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:71766-001-0436 in 1 CARTON10/10/2017
    425 in 1 PACKET
    40.04 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:71766-001-0524 in 1 CARTON10/10/2017
    550 in 1 PACKET
    50.008 g in 1 POUCH; Type 0: Not a Combination Product
    6NDC:71766-001-0624 in 1 CARTON10/10/2017
    680 in 1 PACKET
    60.128 g in 1 POUCH; Type 0: Not a Combination Product
    7NDC:71766-001-0724 in 1 CARTON10/10/2017
    7100 in 1 PACKET
    70.16 g in 1 POUCH; Type 0: Not a Combination Product
    8NDC:71766-001-084 in 1 CARTON10/10/2017
    8800 in 1 PACKET
    81.28 g in 1 POUCH; Type 0: Not a Combination Product
    9NDC:71766-001-094 in 1 CARTON10/10/2017
    91200 in 1 PACKET
    91.92 g in 1 POUCH; Type 0: Not a Combination Product
    10NDC:71766-001-1012 in 1 CARTON10/10/2017
    10250 in 1 PACKET
    100.4 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/10/2017
    Labeler - Hangzhou Linkeweier Daily Chemicals Co., Ltd. (544544821)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Linkeweier Daily Chemicals Co., Ltd.544544821manufacture(71766-001)