Active Ingredients
Benzalkonium Chloride 0.4%
Benzalkonium Chloride Antiseptic
FDA Label NDC 35617-393
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nantong Strip Medical Supply Co.,ltd. for the product Benzalkonium Chloride Antiseptic (NDC 35617-393). 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, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use
Prevent infection in minor scrapes
Warnings
For external use onlyFlammable,keep away for fire or flameDo not use: * In large quantities * over large areas of the body * in eyes * over raw or blistered areasStop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.
Directions
Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily.Children under 2 years of age ; Consult a doctor
Inactive Ingredient
Purified Water
* Please review the disclaimer below.
