Label: CHEMSTATION E2- chloroxylenol soap

  • NDC Code(s): 71212-103-00, 71212-103-01, 71212-103-02
  • Packager: Chemstation
  • 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 2, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Chloroxylenol 1.5% w/w

  • PURPOSE

    Purpose

    Antiseptic Hand Cleanser

  • INDICATIONS & USAGE

    Uses

    • handwash to help reduce bacteria that potentially can cause disease
    • helps to prevent cross contamination by hand contact
    • helps to prevent drying of the skin
    • recommended for repeated use
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product do not use in or near the eyes.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develop.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • wet hands and wrists with clean, running water
    • apply appropriate amount of product
    • lather and scrub hands, fingers, fingernails, cuticles and wrists for at least 20 seconds
    • rinse thoroughly with running water
    • dry hands completely (incomplete drying may lead to chapped skin)
  • STORAGE AND HANDLING

    Other Information

    store in a cool, dry place below 104° F (40° C)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, sodium laureth sulfate, isopropyl alcohol, phenoxyethanol, glycerine, TetraSodium EDTA, citric acid, sodium hydroxide

  • QUESTIONS

    Questions?

    Contact ChemStation at 800-554-8625 Mon-Fri 9am - 5pm EST

  • OTHER SAFETY INFORMATION

    Can cause eye irritation.

    Prevention: Keep away from heat/sparks/open flames/hot surfaces - No Smoking. Use only non-sparking tools. Keep container tightly closed.

    Response:

    IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention.

    IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin (hair) with water.

    IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.

    In case of fire: Use CO 2 dry chemical, or foam for extinction.

    Storage: Stored in a well-ventilated place. Keep Cool.

    Disposal: Dispose of contents/container to an approved waste disposal plant.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    ChemStation Buyers Association, Inc.

    3400 Encrete Lane

    Dayton, OH 45439

    www.chemstation.com

  • PRINCIPAL DISPLAY PANEL

    CHEMSTATION®

    E2 Sanitizing Foam Soap

    Chloroxylenol (PCMX)

    Rich, thick foam

    Our System Is The Solution

    Net Contents: 55 U.S. Gallons (208.198 liters)

    CS10027 E2 55 Gal

  • INGREDIENTS AND APPEARANCE
    CHEMSTATION E2 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71212-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL15 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71212-103-014 in 1 BOX03/08/2017
    13.79 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:71212-103-00208.198 L in 1 DRUM; Type 0: Not a Combination Product03/08/2017
    3NDC:71212-103-026 in 1 BOX03/08/2017
    31.25 L in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/08/2017
    Labeler - Chemstation (177350279)
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