Label: T-CHEM E2 RATED- chloroxylenol, triclosan 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 January 15, 2022

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:

    Chloroxylenol 0.45%

    Triclosan 0.06%

  • PURPOSE

    PURPOSE:

    Antiseptic

  • WARNINGS

    FIRST AID:

    EYES: AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER. CALL PHYSICIAN IF IRRITATION OR REDNESS DEVELOPS AND LASTS.

    INGESTION: IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL OR CONTACT A POISON CNTROL CENTER IMMEDIATELY.

    CONTAINER DISPOSAL: RINSE THREE TIMES WITH WATER. THEN OFFER FOR RECYCLING OR RECONDITIONING OR PUNCTURE AND DISPOSE OF IN A SANITARY LANDFILL OR BY INCARCERATION OR, IF ALLOWED BY STATE AND LOCAL AAUTHORITIES, BY BURNING. IF BURNED, STAY AWAY FROM SMOKE.

  • INDICATIONS & USAGE

    USES: Hygienic disinfectant.

  • KEEP OUT OF REACH OF CHILDREN

    FOR USE BY SERVICE PROFESSIONALS ONLY.

    KEEP OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:

    POUR GEL INTO DISPENSER AND USE STRAIIGHT; DO NOT DILUTE. WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING. FOR EXTERNAL USE ONLY.

  • PRINCIPAL DISPLAY PANEL

    Label1095-E2Soap032814

  • INGREDIENTS AND APPEARANCE
    T-CHEM E2 RATED 
    chloroxylenol, triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50536-192
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.45 g  in 100 mL
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.06 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50536-192-12800 mL in 1 BOTTLE; Type 0: Not a Combination Product03/12/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/12/2014
    Labeler - AMERICAN CHEMICAL AND SANITARY SUPPLY INC (177148699)
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