The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals, Inc. for the product Wound Wash Antiseptic Saline With Benzalkonium Chloride (NDC 13709-235). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding wound wash antiseptic saline with benzalkonium chloride, dosage & administration, warnings, inactive ingredient, indications & usage, otc - purpose, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Benzalkonium Chloride 0.13% (refer attached image: Woundwash with BKC.jpg)
Wound Wash Antiseptic Sterile Saline with Benzalkonium Chloride, 75 mL, see attached image file (WoundWash with BKC.jpg)
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.
Do not use on burn injusries. 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.
USP Grade Water, USP Sodium Chloride (9 mg/mL)
First Aid Antiseptic
First aid to cleanse minor cuts, wounds, and scrapes
First aid to cleanse minor cuts, wounds and scrapes
Keep out of reach of children
* Please review the disclaimer below.
