Label: DERMAL WOUND CLEANSER- benzethonium chloride spray

  • 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 October 20, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENTS

    Benzethonium Chloride 0.13%

  • PURPOSE

    First aid antiseptic

  • USES

    • first aid to help reduce the risk of infection in minor cuts, scrapes and burns
    • aids in the removal of foreign materials such as dirt and debris
  • WARNINGS

    • For external use only

    • Do not use in the eyes or apply over large areas of the body

    • In case of deep or puncture wounds, animal bites, or serious burns, contact a doctor
    • Stop use and contact a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately
  • DIRECTIONS

    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily
    • rinse as per normal protocol
    • cover wound with sterile dressing or bandage as needed
    • if applying dressing or bandage, let dry first
  • OTHER INFORMATION

    • contains antimicrobial ingredient 
  • INACTIVE INGREDIENTS

    benzyl alcohol, citric acid, disodium EDTA, glycerin, polyquaternium-10, polysorbate 20, sodium citrate, water

  • QUESTION OR COMMENTS?

    1 800 876-1261

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - DERMAL WOUND CLEANSER BOTTLE, SPRAY (473 mL)

    Smith&Nephew

    REF 449000
    NDC 69740-490-00

    Dermal
    Wound
    Cleanser

    First Aid Antiseptic

    • Helps reduce risk of infection in wounds and burns
    • Gentle wound cleansing
    • Safe and easy to use
    • pH-buffered
    • Non-irritating

    16 fl. oz. (473 mL)

    Made in the USA for Smith & Nephew Medical Ltd.
    101 Hessle Road
    Hull
    HU3 2BN
    England
    www.smith-nephew.com

    Package Display - Bottle, Spray (473mL)

  • PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - DERMAL WOUND CLEANSER BOTTLE, SPRAY (236 mL)

    Smith&Nephew

    #59449200

    NDC 69740-492-00

    Dermal
    Wound
    Cleanser

    First Aid Antiseptic

    • Helps reduce risk of infection in wounds and burns
    • Gentle wound cleansing
    • Safe and easy to use
    • pH-buffered
    • Non-irritating

    8 fl. oz. (236 mL)

    Made in the USA for Smith & Nephew Medical Ltd.
    101 Hessle Road
    Hull
    HU3 2BN
    England
    www.smith-nephew.com

    Package Display - Bottle, Spray (236mL)

  • INGREDIENTS AND APPEARANCE
    DERMAL WOUND CLEANSER 
    benzethonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-490
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.3 g  in 981 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69740-490-00473 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/1994
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/1994
    DERMAL WOUND CLEANSER 
    benzethonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69740-492
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.3 g  in 981 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69740-492-00236 mL in 1.0 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/1991
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/1991
    Labeler - Smith & Nephew Medical Ltd. (216344051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933MANUFACTURE(69740-490, 69740-492) , analysis(69740-490, 69740-492) , pack(69740-490, 69740-492)
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