Label: GUARDEX SANITIZING HAND- benzalkonium chloride lotion

  • 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 December 26, 2020

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  • Active Ingredients

    Benzalkonium Chloride 0.095%

  • Purpose

    Antiseptic

  • Uses

    For hand cleaning reduce bacteria that potentially can cause disease and moisture your hands.

  • Warnings

    For external use only

  • Stop use and ask a doctor

    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

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

    • Do not store above 105 °F
    • May discolor some fabrics
  • Inactive Ingredients

    Water, Caprylic/Capric Glycerides, Ethylhexyl Palmitate, Ammonium Polyacrylate, C13-C16 Isoparaffin, Laurath-30, Phenoxyethanol, Butyrospermum Parkii (Shea Butter), Cetearyl Alcohol, Fragrance, Panthenol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Maltodextrin.

  • PRINCIPAL DISPLAY PANEL

    image of tube label

  • INGREDIENTS AND APPEARANCE
    GUARDEX SANITIZING HAND 
    benzalkonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81353-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.95 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LAURETH-30 (UNII: W9D845551A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81353-126-0176.89 mL in 1 TUBE; Type 0: Not a Combination Product12/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/26/2020
    Labeler - Nile Hudson LLC (129371101)
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