WOUND WASH ANTISEPTIC SALINE WITH BENZALKONIUM CHLORIDE AEROSOL, SPRAY [NEILMED PHARMACEUTICALS, INC.]

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WOUND WASH ANTISEPTIC SALINE WITH BENZALKONIUM CHLORIDE AEROSOL, SPRAY [NEILMED PHARMACEUTICALS, INC.]
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NDC 13709-235-11
Set ID 55a1fc63-2527-4033-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager NeilMed Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Dosage and Administration

    Before use, spray a short stream in the air or on intact skin to test spray pattern and to clear nozzle.

    To dispense, aim nozzle at the affected area and spray from a distance of 2 to 4 inches, or as is comfortable.

    Cover with clear cap after each use

  • Warnings

    Do not use on burn injuries. Do not use in body orifices, ear canals, eyes or mouth.

    Not for injection.

    For individual use only.

    Apply as needed. Consult a healthcare professional for continued wound care management and for use on children younger than 2 years of age.

  • Inactive Ingredients

    USP Grade Water, USP Sodium Chloride (9mg/mL)

  • OTC Active Ingredient

    Benzalkonium Chloride 0.13%

  • Indications and Usage

    First Aid Antiseptic

    First aid to cleanse minor cuts, wounds and scrapes

  • OTC- Purpose

    First aid to cleanse minor cuts, wounds and scrapes

  • OTC- Keep Out of Reach of Children

    Keep out of reach of children.

  • Wound Wash Antiseptic Sterile Saline with Benzalkonium Chloride, 75 mL

    Wound Wash 75ml

  • INGREDIENTS AND APPEARANCE
    WOUND WASH ANTISEPTIC SALINE WITH BENZALKONIUM CHLORIDE 
    wound wash antiseptic saline with benzalkonium chloride aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 89.7 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-235-1175 mL in 1 CAN; Type 0: Not a Combination Product01/02/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/02/2017
    Labeler - NeilMed Pharmaceuticals, Inc. (799295915)
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