Label: WOUND CLEANSER spray

  • NDC Code(s): 67777-403-01, 67777-403-02
  • Packager: Dynarex Corporation
  • 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 February 3, 2023

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  • Active Ingredient

    Benzethonium Chloride 0.13%

  • Purpose

    First Aid Antibiotic

  • Use(s)

    First aid to help prevent infection in minor cuts, scrapes, and burns

  • Warnings

    For External Use Only

    Do not use

    • In the eyes or over large areas of the body

    • Longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have

    deep or puncture wounds, animal bites, or serious burns.

    Stop use and ask a doctor if

    if condition persists or gets worse.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Clean the affected area

    • Spray 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

    • Store at room temperature 15°-30ºC (59º-86ºF)

    • Avoid excessive heat

  • Inactive ingredients

    Benzyl Alcohol, Disodium Edetate, Glycerin, Polyquaternium 10, Polysorbate 20, Purified Water, Sodium Citrate.

  • Label

    3005-IN-MASTER

  • INGREDIENTS AND APPEARANCE
    WOUND CLEANSER 
    wound cleanser spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-403-0224 in 1 CASE02/13/2017
    1NDC:67777-403-01236.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/13/2017
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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