Label: HAND ESSENTIALS ANTIBACTERIAL- chloroxylenol 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 June 4, 2020

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  • Active ingredient

    PCMX (para-chloro-meta-xylenol) 0.6%

  • Purpose

    Antiseptic

  • Use

    for handwashing to decrease bacteria on skin

  • Warnings

    For external use only.

    When using this product:

    • Do not get in eyes.
    • If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • irritation and redness develop.

    Keep out of reach of children.

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

  • Directions

    • Ready to use.
    • Do not dilute.
    • Wet hands and forearms.
    • Apply 5 ml (tsp) or palmful to hands and forearms.
    • Scrub thoroughly for 1 minute and rinse.
  • Inert ingredients

    Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropylbetaine, Tetrasodium EDTA, Propylene Glycol, Fragrance, Sodium Chloride, Boric Acid, Glycol Stearate, PEG-75 Lanolin, DMDM Hydantoin, Aloe Vera.

  • PRINCIPAL DISPLAY PANEL

    Hu-Friedy

    HAND ESSENTIALS

    ANTIBACTERIAL SOAP

    Effective against a broad

    spectrum of activity

    against gram negative and

    gram positive bacteria.

    Contains emollients to

    help moisten skin and

    maintain its natural oils.

    473 ml/16.0 FL. OZ.

    NDC: 65626-018-16

    Manufactured for:

    Hu-Friedy Nfg. Co., LLC

    3232 N. Rockwell St. Chicago, IL 60618

    1-800-Hu-Friedy Hu-Friedy.com

    MADE IN USA

    Hu-Friedy

    container labela

  • INGREDIENTS AND APPEARANCE
    HAND ESSENTIALS ANTIBACTERIAL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65626-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORIC ACID (UNII: R57ZHV85D4)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65626-018-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/04/2020
    Labeler - Hu-Friedy Mfg. Co. LLC (005085972)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vintage Chemical Inc116949970manufacture(65626-018)
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