HAND SANITIZER (BENZETHONIUM CHLORIDE) GEL [BIOLAB INTERNATIONAL INCORPORATED]

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HAND SANITIZER (BENZETHONIUM CHLORIDE) GEL [BIOLAB INTERNATIONAL INCORPORATED]
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NDC 72264-002-01
Set ID 6a310cda-3d6c-3d98-e053-2a91aa0ad6a3
Category HUMAN OTC DRUG LABEL
Packager Biolab International Incorporated
Generic Name
Product Class
Product Number
Application Number PART333A
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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:72264-002
    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:72264-002-01100 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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