Label: SANITIZING WIPES- benzalkonium chloride wipes 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 July 27, 2020

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  • Active Ingredient(s)

    Label• Benzalkonium Chloride 0.13% / Purpose: Antimicrobial

  • Purpose

    Antimicrobial, Hand Sanitizer

  • Use

    • For hand sanitizing to decrease bacteria on the skin.

  • Warnings

    • For external use only
    • When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
    • Stop use and ask a doctor if irritation or redness appears
    • Keep out of reach of children unless under adult supervision.

    • If swallowed, get medical help or contact Poison Control
    Center right away. Call 1-800-222-1222.

  • Directions

    • Take wipe and rub thoroughly over all surfaces of both hands.
    • Dispose of wipe after use

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children unless under adult supervision.

  • Other information

    • Store in a cool dry place.

  • Inactive ingredients

    • Aqua, vitamin E, glycerin, aloe vera leaf extract, chamomile flower extract, centella & houttuynia, asiatica extract, decyl glucoside, citric acid, sodium citrate, silver citrate

  • Package Label - Principal Display Panel

    48 wipes. NDC: 79431-101-06.

    FrontBack

  • INGREDIENTS AND APPEARANCE
    SANITIZING WIPES 
    benzalkonium chloride wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79431-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.00013 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILVER CITRATE (UNII: CKA421A1J7)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79431-101-066 mg in 1 POUCH; Type 0: Not a Combination Product07/31/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/31/2020
    Labeler - Forsit (695538758)
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