HAND SANITIZER (BENZETHONIUM CHLORIDE) GEL [RIMPORTS INC.]

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HAND SANITIZER (BENZETHONIUM CHLORIDE) GEL [RIMPORTS INC.]
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NDC 72131-003-01
Set ID 676f6d45-5640-8c7b-e053-2991aa0a1b41
Category HUMAN OTC DRUG LABEL
Packager RIMPORTS INC.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • ACTIVE INGREDIENT

    Active Ingredient:
    Benzethonium Chloride 0.105%

  • PURPOSE

    Purpose

    Antiseptic

  • STOP USE

    Stop use and ask a doctor if redness appears and persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. If swallowed, contact medical help or poison control.

  • DOSAGE & ADMINISTRATION

    Directions Spray on palm and rub your hands together until absorbed.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, PEG-40 Hydrogenated Castor Oil, Betaine, Fragrance, Citrus Aurantium Dulcis (Orange) Peel Oil, Zingiber Offincinale (Ginger) Root Oil,, Phenoxyethanol, Diazolidinyl Urea, Palmitamidopropyltrimonium Chloride, Sodium Citrate, Disodium EDTA.

  • OTHER SAFETY INFORMATION

    Other Information

    May damage fabrics and surfaces.

  • INDICATIONS & USAGE

    Uses

    For waterless hand washing to decrease bacteria on skin. Recommended for repeated use.

  • WARNINGS

    WARNINGS:

    For external use only.

  • WHEN USING

    When using this product, Avoid face, eyes or sensitive areas. If contact occurs flush thoroughly with water.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzethonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72131-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.105 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    BETAINE (UNII: 3SCV180C9W)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414)  
    WATER (UNII: 059QF0KO0R)  
    PALMITAMIDOPROPYLTRIMONIUM CHLORIDE (UNII: N2U96D202F)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72131-003-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/06/2018
    Labeler - RIMPORTS INC. (361320844)
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