Active Ingredient
Benzalkonium Chloride 0.13%
Antiseptic Spray
FDA Label NDC 67777-012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Antiseptic (NDC 67777-012). 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 active ingredient, purpose, use(s), warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First Aid Antiseptic
Use(S)
First aid to help prevent infection in minor cuts, scrapes, and burns
Warnings
For External Use Only
Flammable. Keep away from fire or flame.
Do Not Use
• Near eyes or mucous membranes • Over large areas of the body • More 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
• Irritation and redness develop • 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 and spray 1 to 3 times daily
• May be covered with a sterile bandage
• If bandaged, let dry first
• Children under 12 years of age: Consult a doctor before use
Other Information
• Store at 20°-25°C (68°-77°F)
• Avoid excessive heat
Inactive Ingredients
Ethyl Alcohol, Purified Water
Questions?
1-888-Dynarex Monday - Friday, 9AM - 5PM EST
Label
1167_in_master (1167 In Master R240215 1)
* Please review the disclaimer below.
