Label: BENZALKONIUM CHLORIDE- hand sanitizing 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 October 14, 2022

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  • Active ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    • For hand sanitizing to decrease bacteria on the skin
    • Apply topically to the skin to help prevent cross contamination
    • Recommended for repeated use
    • Dries in seconds
  • Warnings

    For external use only.

    May irritate eyes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children unless under adult supervision

  • Directions

    • Remove lid
    • Pull wipe from center of roll and thread through opening in lid

    Do not push finger through opening

    • Replace lid, pull wipe up, and then out 45º angle

    The next wipe dispenses automatically

    • Close lid to retain moisture

  • Inactive ingredient

    Aloe Barbadensis Leaf Juice, Disodium EDTA, DMDM Hydantoin, Ethylparaben, Fragrance, Methylparaben, Phenoxyethanol, Polysorbate 20, Sodium Citrate, Water

  • Principal Display Panel

    wipesplus

    HAND SANITIZING

    alcohol wipes

    lemon scent

    Kills 99.9% of germs

    pic 1

    1500

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE 
    hand sanitizing wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67151-313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLPARABEN (UNII: 14255EXE39)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67151-313-04240 in 1 CANISTER03/29/2022
    11 mg in 1 CANISTER; Type 0: Not a Combination Product
    2NDC:67151-313-091500 in 1 CANISTER03/29/2022
    21 mg in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/29/2022
    Labeler - Progressive (127111792)
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