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 November 27, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient:
    Benzethonium Chloride 0.095%

  • PURPOSE

    Purpose

    Antiseptic

  • STOP USE

    Stop using this product and consult a doctor if irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • Rub dime sized amount between hands until dry.
    • For use by children under 6 years, adult supervision is required.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Fragrance, Glycerin, Methylisothiazolinone, PEG-40 Hydrogenated Castor Oil, Polyquatemium-37, Propylene Glycol, Triethanolamine, Water,

  • INDICATIONS & USAGE

    Uses

    To help reduce bacteria on hands.

  • WARNINGS

    Warnings:

    For external use only.

  • WHEN USING

    When using this product,

    • Avoid contact with eyes and lips.
    • If contact occurs, rinse 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:72707-001
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYQUATERNIUM 37 (200 MPA.S) (UNII: 67C1D6YV24)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72707-001-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/27/2018
    Labeler - DISNEY DESTINATIONS,LLC (079603310)
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