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 March 15, 2018

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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, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf 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:72131-001
    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)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    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:72131-001-0159 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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