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Dermal Wound Cleanser (Smith & Nephew, Inc.)

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SPRAY 236 mL in 1 BOTTLE, SPRAY (50484-490-00) Label Information

Complete Dermal Wound Cleanser Information

  • 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
    • for washing small superficial wounds
    • 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, consult a doctor
    • Stop use and consult 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
    • may be covered with a sterile bandage
    • if bandaged, 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


  • PRINCIPAL DISPLAY PANEL

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

    Smith&Nephew

    #449000
    NDC 50484-490-00

    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. (473mL)


    Made for:
    Smith & Nephew, Inc.
    St. Petersburg, FL 33716
    www.smith-nephew.com

    Package Display - Bottle, Spray (473mL)



  • PRINCIPAL DISPLAY PANEL

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

    Smith&Nephew

    #59449200
    NDC 50484-492-00

    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. (236mL)

    Made for:
    Smith & Nephew, Inc.
    St. Petersburg, FL 33716
    www.smith-nephew.com


    Package Display - Bottle, Spray (236mL)


  • INGREDIENTS AND APPEARANCE
    DERMAL WOUND CLEANSER 
    benzethonium chloride spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50484-492
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 1.3 ug  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 5 uL  in 1 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 ug  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 10 ug  in 1 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 30 ug  in 1 mL
    WATER (UNII: 059QF0KO0R) 927 uL  in 1 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 15 ug  in 1 mL
    CITRIC ACID ACETATE (UNII: DSO12WL7AU) 0.5 ug  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-492-00 473 mL in 1.0 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package 04/01/1994 06/30/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 04/01/1994 06/30/2018
    DERMAL WOUND CLEANSER 
    benzethonium chloride spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50484-490
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE 1.3 ug  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZYL ALCOHOL (UNII: LKG8494WBH) 5 uL  in 1 mL
    WATER (UNII: 059QF0KO0R) 927 uL  in 1 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.2 ug  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 10 ug  in 1 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 30 ug  in 1 mL
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 15 ug  in 1 mL
    CITRIC ACID ACETATE (UNII: DSO12WL7AU) 0.5 ug  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50484-490-00 236 mL in 1.0 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package 04/01/1991 06/30/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 04/01/1991 06/30/2018
    Labeler - Smith & Nephew, Inc. (827731451)
    Establishment
    Name Address ID/FEI Business Operations
    Swiss-American CDMO, LLC 080170933 MANUFACTURE(50484-490, 50484-492)