Label: AL-SHIELDS ANTIBACTERIAL 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 August 7, 2020

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antibacterial

  • Use

    Hand wipes to help reduce 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 rash appears and lasts

    Keep out of the reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and allow to dry
    • Discard wipes in trash receptacle after use. Do not flush
    • Children under 6 years of age should be supervised when using this product
  • Inactive ingredients

    Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyaminopropyl biguanide, Propylene Glycol, Purified water, Fragrance

  • Questions or Comments?

    CALL 1-855-929-3829 (M-F)

  • SPL UNCLASSIFIED SECTION

    KILLS 99.99% OF GERMS

    FRESH ALOE SCENT

    TO DISPENSE:

    Peel back front label slowly.

    Remove wipe.

    TO RESEAL:

    Press down label to reseal.

    TO DISPOSE:

    Place in water basket after use.

    DO NOT FLUSH

    SHOP WITH US AT

    WWW.AL-SHIELDS.COM

    QUESTIONS? CONTANT US AT

    CONTACTUS@AL-SHIELDS.COM

    Distributed by GMA Group

    3 Empire Boulevard

    South Hackensack, NJ 07686

    Phone: 1-855-929-3829

    Made in China

    SHOP WITH US AT

    WWW.AL-SHIELDS.COM

    QUESTIONS? CONTACT US AT

    CONTACTUS@AL-SHIELDS.COM

  • Packaging

    IMAGEIMAGEIMAGEIMAGEIMAGEIMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    AL-SHIELDS ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79848-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79848-100-0110 in 1 BAG08/04/2020
    13.78 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:79848-100-0220 in 1 BAG08/04/2020
    23.78 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:79848-100-0530 in 1 BAG08/04/2020
    33.78 mL in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:79848-100-0340 in 1 CANISTER08/04/2020
    43.78 mL in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:79848-100-0470 in 1 CANISTER08/04/2020
    53.78 mL in 1 PACKAGE; Type 0: Not a Combination Product
    6NDC:79848-100-061 in 1 PACKET08/04/2020
    63.78 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/04/2020
    Labeler - Gma Accessories Inc. (041610135)
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