Label: ANTIBACTERIAL HAND- chloroxylenol soap

  • NDC Code(s): 0404-4438-01, 0404-4438-02, 0404-4438-03
  • Packager: Henry Schein, 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 January 26, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Chloroxylenol (PCMX) 0.6%

  • Purpose

    Antiseptic

  • Uses

    For handwashing to decrease bacteria on skin. Recommended for repeated use.

  • Warnings

    For external use only.

    When using this product

    • supervise children under 6
    • do not use in the eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask doctor if irritation or redness develop and persist for more than 72 hours.

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    Wet hands and forearms. Apply 5 milliliters (teaspoonful) or palmful to hands and forearms. Scrub thoroughly for 30 seconds. Rinse and repeat.

  • Inactive ingredients

    aloe vera, cocamide DEA, cocamidopropyl betaine, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

  • PRINCIPAL DISPLAY PANEL – 473 mL (16 fl. oz.) bottle

    Henry Schein

    Antibacterial

    HAND SOAP

    Cucumber & Aloe

    Jabón de manos
    antibacteriano

    Savon antibactérien
    pour les mains

    Distributed by:
    Distribuido por: Distribué par:
    HENRY SCHEIN, Inc.
    135 Duryea Road
    Melville, NY 11747 USA

    16 fl. oz. • 473 ml

    PRINCIPAL DISPLAY PANEL – 473 mL (16 fl. oz.) bottle
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-4438
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q) chloroxylenol6.10 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    coco diethanolamide (UNII: 92005F972D)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    diazolidinyl urea (UNII: H5RIZ3MPW4)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    sodium laureth-3 sulfate (UNII: BPV390UAP0)  
    edetate sodium (UNII: MP1J8420LU)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-4438-010.473 L in 1 BOTTLE; Type 0: Not a Combination Product01/30/2013
    2NDC:0404-4438-020.237 L in 1 BOTTLE; Type 0: Not a Combination Product01/30/2013
    3NDC:0404-4438-033.785 L in 1 BOTTLE; Type 0: Not a Combination Product01/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/30/2013
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0404-4438)