Label: AMERFRESH ANTIBACTERIAL- 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 August 16, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzethonium Chloride 0.1%

  • Purpose

    Antibacterial

  • Uses

    For washing to decrease bacteria on skin.

  • Warnings

    For External Use Only.

  • WHEN USING

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

  • DO NOT USE

    Do not use this product on infants under 6.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • Directions

    • Wet bar with water
    • Lather vigorously and wash skin
    • Rinse and dry thoroughly
  • Inactive Ingredients

    Soap (Sodium Palmate and/or Sodiun Tallowate. Sodium Cocoate and/or Sodium Palm Kernelate) Water, Palm Acid, Glycerin, Sodium Chloride, Coconut Acid,Fragrance, Tetrasodium EDTA, Citric Acid Anhydrous.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    AMERFRESH ANTIBACTERIAL 
    benzethonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73343-004
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    COCONUT ACID (UNII: 40U37V505D)  
    PALM ACID (UNII: B6G0Y5Z616)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73343-004-011 in 1 CASE08/15/2020
    185 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/15/2020
    Labeler - Yangzhou Tracey Daily Chemical Plastic Co., Ltd. (560398069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Tracey Daily Chemical Plastic Co Ltd560398069manufacture(73343-004)
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