Label: EPIC- chloroxylenol soap

  • NDC Code(s): 74146-237-63, 74146-237-64, 74146-237-79, 74146-237-80
  • Packager: GM Industrial, Inc.
  • 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 June 9, 2021

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  • BOXED WARNING (What is this?)

    Chloroxylenol 0.3%

    Antiseptic

    Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use

    Warnings

    For external use only

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

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

    Directions

    • Wet hands and forearms
    • Apply enough product to adequately cover the entire surfaces of the hands and forearms
    • Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
    • Rinse thoroughly with water.

    Other Information

    • Store in a cool dry place below 104°F

    Inactive Ingredients

    Water, Propylene Glycol, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Sodium Chloride, Glycerin, Magnesium Nitrate, Methylchloroisothiazolinone, Methylisothiazolinone.

  • 2.5 L PDP CHEM EPIC

    2.5 L pdp 74146-237-79 2.5 L NDC: 74146-237-79

  • 2.5 L PDP ZENEX EPIC

    2.5 L NDC: 74146-237-772.5 L pdp 74146-237-77

  • 3.5 L PDP CHEM EPIC

    3.5 L 74146-237-75 3.55 L NDC: 74146-237-75

  • 3.5 L PDP ZENEX EPIC

    3.55 L 74146-237-73 3.55 L NDC: 74146-237-73

  • INGREDIENTS AND APPEARANCE
    EPIC 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74146-237
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74146-237-804 in 1 BOX06/09/2023
    1NDC:74146-237-792500 mL in 1 JUG; Type 0: Not a Combination Product
    2NDC:74146-237-644 in 1 BOX06/09/2023
    2NDC:74146-237-633785.41 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/09/2023
    Labeler - GM Industrial, Inc. (025827197)
    Establishment
    NameAddressID/FEIBusiness Operations
    GM Industrial, Inc.025827197manufacture(74146-237) , pack(74146-237) , label(74146-237) , repack(74146-237) , relabel(74146-237)
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