Otc - Purpose
Hand and Skin Sanitizer
Pre Fense Unscented Liquid
FDA Label NDC 48404-050
8 label sections · Submitted to the FDA by Prefense Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prefense Llc for the product Pre Fense Unscented (NDC 48404-050). 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 - purpose, otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label - 1.5 fl. oz. bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Drug Facts
Active Ingredient
Benzalkonium Chloride ............0.12%
Indications & Usage
Hand sanitizer to help reduce germs that potentially cause disease.
Warnings
For external use only. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Apply to dry hands, rub together, and let dry.
Inactive Ingredient
3-Chloropropyltrimethoxysilane, Acetic Acid, Anhydrous Citric Acid, Cocomidoprophyl betaine, Octadecyldimethyl (3-trimethoxysilylpropyl)ammonium chloride, Isotonic Sodium Chloride Solution, Water
Package Label - 1.5 Fl. Oz. Bottle Label
pre•fense ™
Hand Sanitizer
Unscented
protects
kills up to 99.99% of germs on contact
Moisturizes
silica based, alcohol-free
alcohol-free
won't dry out skin
120 Pumps
1.5 fl. oz.
1 (Prefense Hs Label 1.5oz Unsc Ol)
* Please review the disclaimer below.
