Label: ANTIMICROBIAL HAND WASH- chloroxylenol soap

  • NDC Code(s): 0404-5987-01, 0404-5987-02
  • Packager: Henry Schein, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 July 29, 2016

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  • 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 do not get into eyes. If contact occurs, rinse eyes thoroughly with water

    Stop use and ask doctor if

    • irritation and redness develops and persists 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
    • supervise children under 6 years of age
  • Inactive Ingredients

    aloe vera, cocamide DEA, cocamidopropyl betaine, D&C Red #33, fragrance, germaben II, propylene glycol, purified water, sodium chloride, sodium laureth sulfate, tetrasodium EDTA, vitamin E acetate

    Distributed by HENRY SCHEIN, INC. Melville, NY 11747 USA

    Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL – 800 mL Box

    Henry Schein

    112-5987

    Maxiclens

    Antimicrobial Hand Wash

    NDC 0404-5987-01

    27.05 FL. OZ. (800 ML)

    PRINCIPAL DISPLAY PANEL – 800 mL Box
  • PRINCIPAL DISPLAY PANEL – 1.68 mL Packet

    Henry Schein

    Maxiclens

    Antimicrobial

    Hand Wash

    With PCMX

    To Order: Contact your
    Henry Schein Sales Rep

    0.0570 fl.oz. (1.68 ML)

    Distributed by

    HENRY SCHEIN, Inc.

    Melville, NY 11747 USA

    Made in U.S.A.

    PRINCIPAL DISPLAY PANEL – 1.68 mL Packet
  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL HAND WASH 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-5987
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q) chloroxylenol6.0 mg  in 1000 mL
    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 sulfate (UNII: BPV390UAP0)  
    edetate sodium (UNII: MP1J8420LU)  
    alpha-tocopherol acetate (UNII: 9E8X80D2L0)  
    propylparaben (UNII: Z8IX2SC1OH)  
    methylparaben (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-5987-01800 mL in 1 BOX; Type 0: Not a Combination Product03/01/2012
    2NDC:0404-5987-021.68 mL in 1 POUCH; Type 0: Not a Combination Product03/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/07/2012
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0404-5987)
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