WOUND CLEANSER SPRAY [DYNAREX CORPORATION]

WOUND CLEANSER SPRAY [DYNAREX CORPORATION]
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NDC 67777-403-01
Set ID 6a4dd82a-6b06-426b-9afd-415a1a4339b4
Category HUMAN OTC DRUG LABEL
Packager Dynarex Corporation
Generic Name
Product Class
Product Number
Application Number PART333A
  • ACTIVE INGREDIENT

    Active ingredient                                               Purpose

    Benzethonium chloride 0.13%  v/v                    First aid antiseptic

  • Use

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

  • Warnings

    For External Use Only

  • DO NOT USE

    Do not use

    • in the eyes or over large areas of the body.
    • longer than 1 week unless directed by a doctor
  • ASK DOCTOR

    Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

  • Stop use

    Stop use and consult a doctor if

    • if condition persists or gets worse.
  • KEEP OUT OF REACH OF CHILDREN

    Keep Out Of Reach Of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Mild non-irritating wound cleanser for removing exudates and debris in wounds

  • DOSAGE & ADMINISTRATION

    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

    Other information

    • Store at room temperature
    • Avoid excessive heat
  • Inactive ingredients

    Inactive ingredients: Benzyl alcohol, Edetate disodium, Glycerin, Polyquaternium 10, Polysorbate 20, Purified water, Sodium citrate.

  • PRINCIPAL DISPLAY PANEL

    Dynarex Wound Cleanser

    Item 3005

    3005 Wound.jpg

    Wound Cleanser

  • 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 CHLORIDE1.3 mg  in 1 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:67777-403-01214 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/13/2017
    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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