Otc - Active Ingredient
Active Ingredient
Benzalkonium Chloride 0.13% w/w
Foaming Advanced Antibacterial Hand
FDA Label NDC 43196-213
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 Advanced Antibacterial Hand (NDC 43196-213). 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 Handwash to help decrease bacteria on the skin
Dosage & Administration
Directions To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, rinse.
Warnings
Warnings
For external use only. Avoid contact with eyes. If eye contact occurs, flush eyes with water.
Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.
Inactive Ingredient
Inactive Ingredients
water, cocamidopropyl betaine, cocamidopropyl PG-dimonium chloride phosphate, PEG-6 cocamide, laurtrimonium chloride, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), fragrance, iodopropynyl butylcarbamade, methylisothiazolinone, yellow 5, red 33.
Package Label.Principal Display Panel
Image Description (21309)
Image Description (21324)
Image Description (21341)
Image Description (21350)
Image Description (21378)
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