Label: ANTIBACTERIAL- chloroxylenol liquid

  • 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

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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

    • 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 – 550 mL (18.6 fl. oz.) bottle

    Henry Schein

    Antibacterial

    HAND SOAP

    Spring Water

    Jabón de manos
    antibacteriano

    Savon antibactérien
    pour les mains

    Foaming

    18.6 fl. oz. • 550 ml

    PRINCIPAL DISPLAY PANEL – 550 mL (18.6 fl. oz.) bottle
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-4441
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    chloroxylenol (UNII: 0F32U78V2Q) (chloroxylenol - UNII:0F32U78V2Q) chloroxylenol6.046 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    coco diethanolamide (UNII: 92005F972D)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    edetate sodium (UNII: MP1J8420LU)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-4441-010.55 L in 1 BOTTLE; Type 0: Not a Combination Product01/31/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/31/2013
    Labeler - Henry Schein, Inc. (012430880)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(0404-4441)