Label: ACTIVE GUARD REFILL- benzalkonium chloride liquid

  • 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 January 13, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient

    0.13% Benzalkonium Chloride

  • Purpose

    Antibacterial

  • Use

    Helps reduce bacterial on hands

  • Warning

    For external use only.
    When using this product do not use in or near the eyes.
    In case of contact, rinse eyes throughly with water.

  • Keep out of reach of children

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

  • Directions

    Wash hands and rinse

  • Inactive Ingredients

    Water (Aqua), Cocamidopropyl Betaine, Lauramine Oxide, Cellulose Gum, DMDM Hydantoin, Polysorbate 20, Fragrance, Glycerin

  • DOSAGE & ADMINISTRATION

  • Product Label

    label

  • INGREDIENTS AND APPEARANCE
    ACTIVE GUARD REFILL 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73746-017
    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
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73746-017-011893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/05/2020
    Labeler - HOME & BODY COMPANY (081290720)
    Registrant - HOME & BODY COMPANY (081290720)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOME & BODY COMPANY081290720manufacture(73746-017)