Label: HAND SANITIZER- benzethonium 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 April 18, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient
    Benzethonium Chloride 0.095%

  • PURPOSE

    Purpose

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep it out of children.

  • DOSAGE & ADMINISTRATION

    Directions: Place a small amount of product in your hand, and rub hands together until dry.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water(EAU), Betaine Anhydrous,PEG-40 Hydrogenated Castor Oil, Phenoxyethanol,Diazolidinyl Urea, Palmitamidopropyltrimonium Chloride, Propylene Glycol, Fragrance(Parfum), Sodium Citric Acid, Disodium EDTA.

  • STORAGE AND HANDLING

    Storage: Avoid direct sunlight.

  • INDICATIONS & USAGE

    Uses

    Decrease bacteria on hands.

  • WARNINGS

    WarningsFor external use only.

    In case of contact with eyes, rinse immediately with plenty of water. Discontinue use if rash or irritation occurs and consult a doctor.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzethonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72264-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.095 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    BETAINE (UNII: 3SCV180C9W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PALMITAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: N2U96D202F)  
    DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72264-001-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/18/2018
    Labeler - Biolab International Incorporated (200167919)
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