Otc - Active Ingredient
Active Ingredient
Benzalkonium Chloride 0.13% w/w
Foaming Sanitizing Hand
FDA Label NDC 43196-683
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opi Correctional Industries for the product Foaming Sanitizing Hand (NDC 43196-683). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, 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
Otc - Purpose
Purpose
Antibacterial
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, contact a physician or poison control center.
Indications & Usage
Uses For handwashing to decrease bacteria on skin
Dosage & Administration
Directions Apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.
Warnings
Warnings
For external use only. Do not use in the eyes. If eye contact occurs, flush eyes with water.
Stop use and ask a doctor if redness and irritation occur and last for more than 72 hours.
Inactive Ingredient
Inactive Ingredients
water, cocamidopropyl PG-dimonium chloride phosphate,cocamidopropyl betaine, PEG-6 cocamide, laurtrimonium chloride, iodopropynyl butylcarbamate,methylisothiazolinone.
Package Label.Principal Display Panel
Image Description (22012)
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