Label: SAFEGUARD ANTIBACTERIAL HAND- chloroxylenol liquid

  • NDC Code(s): 69423-053-30, 69423-053-37, 69423-053-80
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 10, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Chloroxylenol 0.5%

  • Purpose

    Antibacterial

  • Use

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

    For external use only.

    Do not use this product on infants under 6 months of age.

    When using this product avoid contact with eyes. If this happens, rinse thoroughly with water.

    Stop use if irritation occurs.

    Keep out of reach of children, except under adult supervision. 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 20 seconds and rinse.

  • Inactive ingredients

    Water, sodium lauryl sulfate, sodium laureth sulfate, cocamide MEA, phenoxyethanol, glycol distearate, cocamidopropyl betaine, sodium sulfate, citric acid, fragrance, guar hydroxypropyltrimonium chloride, DMDM hydantoin, tetrasodium EDTA, yellow 5, red 4

  • Questions?

    1-800-332-7787 (professional sizes)

    1-800-595-1375 (personal size)

  • SPL UNCLASSIFIED SECTION

    Distr. by PROCTER & GAMBLE, CINCINNATI, OH 45202.

  • PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label

    Liquid Ready-to-Use

    Safeguard™ Antibacterial Hand Soap

    • Helps remove bacteria from skin

    Chloroxylenol Antibacterial Hand Soap


    3.78 L/1 GALLON

    safeguard

  • INGREDIENTS AND APPEARANCE
    SAFEGUARD ANTIBACTERIAL HAND 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-053-373780 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2015
    2NDC:69423-053-80800 mL in 1 POUCH; Type 0: Not a Combination Product11/01/2015
    3NDC:69423-053-30300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/01/2015
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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