Otc - Active Ingredient
Benzalkonium Chloride - 0.13%
Benzalkonium Chloride
FDA Label NDC 50157-210
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Brands International Corporation for the product Benzalkonium Chloride (NDC 50157-210). 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, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose - Antibacterial
Indications & Usage
Use for handwashing to decrease bacteria on the skin
Warnings
Warning - For external use only - hands only
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
Otc - Stop Use
Stop use and ask a doctor if
- irritaion or redness develops
- condition persists for more than 72 hours
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions
- Wet Hands
- Apply palmful to hands
- scrub thoroughly
- rinse thoroughly
Inactive Ingredient
Inactive Ingredients: Water (Aqua),Acrylates/C10-30 Alkyl Acrylate crosspolymer, Citrtic Acid, Cocamidopropyl Betaine,Cocamide MEA,Decyl Glucoside, DMDM Hydantoin,Sodium Benzoate, Sodium Laureth Sulfate, Sodium Chloride, Sodium Hydroxide, Glycerin, Fragrance,Panthenol (Parfum),PEG-12 Methyl Glucose Dioleate, Polyquatenium 10, Tetrasodium EDTA, Blue 1, Red# 4 (Cl 14700)
Package Label.Principal Display Panel
Cuticura (Cuticura)
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