Label: BENZALKONIUM CHLORIDE- dual action antimicrobial 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 November 29, 2022

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  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses

    For had washing to decrease bacteria on the skin. Recommended for repeated use.

  • Warnings

    For external use only. Do not use over large areas of the bosy or if you are allergic to any of these ingredients.

    When using this product

    avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or redness develops and 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.

  • Directions

    • To use, peel back label, pull out wipe and firmly reseal label to maintain package moisture. Do not remove label.
    • Unfold cloth and rub thoroughly over all surfaces of both hands. Use only once and throw away. After cleansing, dispose of wipe in a trash receptacle. Rub hands together briskly to dry.
  • Inactive ingredients

    water, phenoxyethanol, decyl glucoside, potassium sorbate, sodium benzoate, disodium EDTA, citric acid, aloe barbadensis (aloe) leaf extract, fragrance.

  • Principal Display Panel

    Dual Action

    antibacterial wipes

    150 cleaning wipes

    7 in x 6 in (17.8 cm x 15.24 cm)

    Gentle skin cleansers

    No Rinse

    *Kills 99.9% of germs that may cause illness including E. Coli and MRSA in just 15 seconds

    Non-Alcohol Based Formula

    Skin Moisturizing

    Cleans & Refreshes

    Fresh Scent

    wipes

  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE 
    dual action antimicrobial wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73062-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73062-401-01150 in 1 POUCH; Type 0: Not a Combination Product10/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/26/2021
    Labeler - Avro Enterprises LLC (804030166)
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