Label: WET WIPES- benzalkonium wipes cloth

  • Category: HUMAN OTC DRUG LABEL

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 September 12, 2020

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  • Active Ingredient(s)

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    For external use only

    Do not use in the eyes

    Stop use and ask a doctor if
    irritation and redness develop
    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.

  • Do not use

    Do not use in the eyes

  • WHEN USING

    Stop use and ask a doctor if
    irritation and redness develop
    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.

  • STOP USE

    Stop use and ask a doctor if
    irritation and redness develop
    condition persists for, more than 72 hours

  • 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

    wet hands thoroughly with product and allow to dry without wiping

  • Other information

    /

  • Inactive ingredients

    Water, glycerin, propylene glycol, EDTA disodium salt, phenoxyethanol, aloe vera leaf juice, tocopheryl acetate.

  • Package Label - Principal Display Panel

    77765-015-01 35P

  • INGREDIENTS AND APPEARANCE
    WET WIPES 
    benzalkonium wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77765-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77765-015-0135 in 1 DRUM; Type 0: Not a Combination Product09/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/12/2020
    Labeler - Hangzhou Beitai Daily Commodity Co., Ltd. (412963380)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Beitai Daily Commodity Co., Ltd.412963380manufacture(77765-015)