Label: AMERIDERM ANTIBACTERIAL WASH- parachlorometaxylenol liquid

  • 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 January 13, 2022

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  • Drug Facts Active Ingredient

    Parachlorometaxylenol 0.3% w/w

  • Purpose

    Antiseptic

  • Uses

    • Handwash to help reduce bacteria on the skin that potentially can cause disease
    • Recommended for repeat use
  • Warnings

    • For external use only
    • Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water
    • Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours
  • Keep out of reach of children

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

  • Directions

    • Wet hands with water and dispense sufficient amount of product into cupped palm of hand
    • Wash both hands thoroughly for 15 seconds
    • Rince under running water and dry thoroughly
  • Inactive Ingredients

    Citric Acid Monohydrate, Cocamidopropyl Betaine, Coco Diethanolamide, Disodium Laureth Sulfosuccinate, Edetate Disodium Anhydrous, Ethylhexyl Glycerin, Fragrance, Glyceryl oleate, PEG-7 Glyceryl Cocoate, Phenoxyethanol, Sodium Laureth 3 Sulfate, Sulisobenzone, Water

  • Package Label

    DRUG FACT PANEL

  • INGREDIENTS AND APPEARANCE
    AMERIDERM ANTIBACTERIAL WASH 
    parachlorometaxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-8073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.003 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-8073-21000 mL in 1 POUCH; Type 0: Not a Combination Product06/12/2018
    2NDC:52410-8073-43780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/12/2018
    Labeler - SHIELD LINE LLC (078518916)
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