Label: AMERIWASH- parachlorometaxylenol liquid

  • Category: HUMAN OTC DRUG LABEL

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

    Antimicrobial

  • Uses

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

    • FOR EXTERNAL USE ONLY
  • When using this product

    • Do not use in or near the eyes
    • Incase of eye contact rinse the eyes thoroughly with water
  • Stop use and ask a doctor if

    • Irritation or rash appears or lasts
  • Keep out of reach of children

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

  • Directions

    • Wet hands
    • Apply a small amount of product and work into lather
    • Rinse well and dry hands completely
  • Inactive Ingredients

    Alpha Hexylcinnamaldehyde, Citric Acid Monohydrate, Cocamidopropyl Betaine, Coco Diethanolamide, D&C Red No. 33, DMDM Hydantoin, Edetate Disodium Anhydrous, FD&C Yellow No.5, FD&C Yellow No.6, PEG-7 Glyceryl Cocoate, Sodium Chloride, Sodium, Laureth Sulfate, Sulisobenzone, Water

  • AMERIWASH DRUG FACT PANEL

    Principal Display & Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    AMERIWASH 
    parachlorometaxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-8038
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-8038-3800 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2017
    2NDC:52410-8038-41000 mL in 1 POUCH; Type 0: Not a Combination Product08/01/2017
    3NDC:52410-8038-53780 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2017
    Labeler - SHIELD LINE LLC (078518916)
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