Active Ingredients
Benzalkonium Chloride 0.12%
Antibacterial Bandage
FDA Label NDC 50438-128
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Filo America for the product Antibacterial Bandage (NDC 50438-128). 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 ingredients, purpose, use, warnings, otc - keep out of reach of children, directions, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
First aid to help reduce the risk of infection in minor cuts ,scrapes,and burns.
Warnings
For external use only.
Stop use and consult a doctor if the dondition persists or gets worse .Do not use longer than 1 week unless directed by a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.
Directions
Clean and dry the affected area .Apply a sterile bandage on the area 1 to 3 times daily.
Other information :not intended for use on delicate or sensitive skin.
Inactive Ingredient
None
Package Label.Principal Display Panel
Image Description (81128)
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