Label: MARKET AMERICA ANTIBACTERIAL HAND SANITIZER- benzalkonium chloride spray

  • 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 March 15, 2021

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Use

    • For hand sanitizing to decrease bacteria on the skin.

  • Warnings

    For external use only

    When using this product avoid contact with eyes. In case of contact with eyes, flush eyes with water.

    Stop use and ask a doctor if irritation or rash develops and lasts.

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

  • Other Information

    • May discolor certain fabrics or surfaces

  • Directions

    • wet hands thoroughly with product and rub hands together until dry. • children under 6 years of age should be supervised when using this product • Not recommended for infants

  • Inactive ingredients

    Ionized water, Urea

  • SPL UNCLASSIFIED SECTION

    CONVERT SPENDING INTO EARNING

    alcohol-free

    triclosan-free &

    fragrance free

    Eliminates 99.99% of Germs

    SHOPPING ANNUITY® BRAND

    BAC-D

    BACTERIAL DEFENSE

    Manufactured for Market America, Inc.,
    1302 Pleasant Ridge Rd., Greensboro, NC 27409

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    MARKET AMERICA ANTIBACTERIAL HAND SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76209-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76209-117-0388.7 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/11/2021
    Labeler - Market America, Inc. (797412236)
    Registrant - Cemi International, Inc (015038336)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cemi International, Inc015038336manufacture(76209-117)
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