Label: ALCOHOL-FREE ANTISEPTIC GEL- benzalkonium chloride gel

  • 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 25, 2020

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  • Active Ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria that can potencially cause disease.

    For use when soap and water are not available.

  • WARNINGS

    Do not freeze. For external use only.

    DO NOT USE

    • In children less than 2 months of age
    • On open skin wounds.

    When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs.

    These may be signs of a serious condition.

    Keep out of reach of children.

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

  • Directions

    • Place just one drop on hands to cover all surfaces.
  • OTHER INFORMATION

    • Store below 110F (43C)
    • May discolor certain fabrics or surfaces
  • INACTIVE INGREDIENTS

    Water, hyroxyethyl cellulose, glycerin, methylparaben, propylene glycol, DMDM H

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ALCOHOL-FREE ANTISEPTIC GEL 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76598-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76598-010-014 mL in 1 POUCH; Type 0: Not a Combination Product04/24/2020
    2NDC:76598-010-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    3NDC:76598-010-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    4NDC:76598-010-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    5NDC:76598-010-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    6NDC:76598-010-063780 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    7NDC:76598-010-074500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    8NDC:76598-010-0820000 mL in 1 JUG; Type 0: Not a Combination Product04/24/2020
    9NDC:76598-010-09200000 mL in 1 JUG; Type 0: Not a Combination Product04/24/2020
    10NDC:76598-010-101000000 mL in 1 JUG; Type 0: Not a Combination Product04/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/24/2020
    Labeler - Bioagaves de la Costa, S.A. de C.V. (814644548)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bioagaves de la Costa, S.A. de C.V.814644548manufacture(76598-010)
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