Label: DEODORANT- benzethonium chloride soap

  • 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 2, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient:
    Benzethonium Chloride: 0.1%

  • PURPOSE

    Purpose:

    Antibacterial

  • INDICATIONS & USAGE

    Uses:

    For washing to decrease bacteria on skin

  • WARNINGS

    Warnings:

    External use only

    When using this product, avoid contact with eyes. In case of eye contact, fush with water.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • ASK DOCTOR

    Stop use and ask doctor if irritation and redness develop

  • KEEP OUT OF REACH OF CHILDREN

    Do not use this product on infants under age of 6

    Keep out of reach of children. 

  • DOSAGE & ADMINISTRATION

    Wet bar with water

    Lather vigorously and wash skin

    Rinse and dry thoroughly

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Soap (Sodium Palmate, and/or Sodium Tallowate, Sodium Cocoate, and/or Sodium Palm Kernelate), Calcium Carbonate, Water, Glycerin, Sodium Chloride, Sodium Hydroxide, Fragrance, Tetrasodium EDTA, Etidronate Tetrasodium

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DEODORANT 
    benzethonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73027-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.09 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
    ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73027-001-0112 g in 1 PACKAGE; Type 0: Not a Combination Product04/15/2019
    2NDC:73027-001-0232 g in 1 PACKAGE; Type 0: Not a Combination Product04/15/2019
    3NDC:73027-001-0382 g in 1 PACKAGE; Type 0: Not a Combination Product04/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/15/2019
    Labeler - JIANGSU HANHE DAILY CHEMICALS CO., LTD. (414409758)
    Establishment
    NameAddressID/FEIBusiness Operations
    JIANGSU HANHE DAILY CHEMICALS CO., LTD.414409758manufacture(73027-001)
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