Active Ingredient
Benzalkonium Cl 0.13% w/w
Bactine Liquid
FDA Label NDC 65197-820
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wellspring Pharmaceutical Corporation for the product Bactine (NDC 65197-820). 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, warning, directions, other information, inactive ingredients, questions?, 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
First aid to help prevent bacterial contamination or skin infection in minor cuts, scrapes and burns.
Warning
For external use only. Do not use on or near the eyes. Do not apply to large areas of the body. Ask a doctor before use if -you have - deep or puncture wounds - animal bites - serious burns. Stop use and ask doctor if - condition persists or get worse - symptoms persist for more than 7 days.
Directions
Clean the affected area, apply a small amount of this product on the area 1 to 3 times daily; may be covered with a sterile bandage (let dry first).
Other Information
Avoid excessive heat
Inactive Ingredients
aloe barbadensis leaf extract, edetate disodium, nonoxynol 9, PEG-100 Stearate, propylene glycol, purified water
Questions?
1-844-241-5454 Mon-Fri (8-5 EST) or bactine.com
Bactine Wound Wash Label
Principal Display (Bactine Woundwash 1)
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