Label: ANTIBACTERIAL HAND 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 January 22, 2022

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  • Active Ingredient

    Benzalkonium

    Chloride 0.125%

  • Purpose

    Antimicrobial

  • USES

    *For hand washing to decrease bacteria on skin without requiring water or rinsing.

    *Recommended for repeated use

  • Warnings

    For external use only.

  • When using product

    *Do not use in or near eyes.

    If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    *If irritation and redness persist for more than 72 hours.

  • Keep out of reach of children

    In case of accidental indestion, seek medical attention or contact a poison control center immediately.

  • Directions

    *Wet thoroughly hands with wipe and allow to dry without wiping.

    *Children under six years of age should be supervised when using this product.

  • Inactive Ingredients

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Citric Acid, Decyl Glucoside, Fragrtance, Phenoxyethanol, Potassium Sorbate, Tetrasodium EDTA, Water.

  • PDP

    LabelMEDIC THERAPEUTICS

    ANTIBACTERIAL

    HAND WIPES

    ___________________

    KILLS 99.9% OF GERMS

    Sanitize on the Go

    Active Ingredient -

    Benzalkonium Chloride (0.125%)

    7 x 5.1in (18 x 13 cm)

    20 CT

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES 
    antibacterial hand wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77070-702
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.125 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77070-702-201 g in 1 POUCH; Type 0: Not a Combination Product07/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/17/2020
    Labeler - GoodFibers (105870470)
    Registrant - GoodFibers (105870470)
    Establishment
    NameAddressID/FEIBusiness Operations
    GoodFibers105870470manufacture(77070-702)
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