Label: AMERICA1 HAND WIPES- benzalkonium chloride 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 June 29, 2021

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  • Active ingredient

    Benzalkonium Chloride 0.13% w/w

  • Purpose

    Antibacterial

  • Uses

    For handwashing to decrease bacteria on the skin

  • Warning

    For external use only

  • Do not use

    • In the eyes
    • If you are allergic to any of the ingredients
  • When using this product

    ​if eye contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    if irritation and redness develops and persists for more than 72 hours

  • Keep out of reach of children

    If swallowed, get medical help or contact a Posion Control Center right away.

  • Directions

    • ​Storage: Store at room temperature
    • Dispensing: Remove seal band. Lift tab at front of lid. Pull out wipe and reseal lid. Close lid to retain moisture
    • Use: Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
    • Disposal: Dispose of used wipes in trash receptacle after use. Do not flush

  • Other information

    Production Date, Expiry Date and  Lot Number on side

  • Inactive ingredients

    Benzoic Acid, C12-15 Pareth-12, Dehydroacetic acid, Fragrance, Glycerin, Phenoxyethanol, Purified Water, Tetrasodium Glutamate Diacetate

  • Principal Display Panel

    NDC: 82055-013-90

    America1 + ANTIBACTERIAL HAND WIPES

    MADE IN USA

    KILLS 99.99% OF GERMS*

    * Kills 99.9% of germs that may cause illness| 90 wipes. 6.3 in X 7.1 in | Country of Origin: USA

    Label

  • INGREDIENTS AND APPEARANCE
    AMERICA1 HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82055-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    C12-15 PARETH-12 (UNII: 131316X18L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82055-013-9090 in 1 POUCH; Type 0: Not a Combination Product06/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/29/2021
    Labeler - America1ppe LLC (117585490)
    Registrant - America1ppe LLC (117585490)
    Establishment
    NameAddressID/FEIBusiness Operations
    America1ppe LLC117585490manufacture(82055-013)
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