Otc - Active Ingredient
Active Ingredient
Ethyl Alcohol 70% v/v
Hand Sanitizer With Additive
FDA Label NDC 58418-119
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tropical Enterprises International, Inc. for the product Hand Sanitizer With Additive (NDC 58418-119). 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 - ask doctor, otc - keep out of reach of children, otc - purpose, otc - questions, otc - stop use, otc - when using, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Ask Doctor
Stop use and ask a doctor if irritation and redness develops and persists.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children: If swallowed, seek prompy medical attention.
Otc - Purpose
Uses: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Otc - Questions
Questions: 1-800-535-5053
Otc - Stop Use
Stop Use Section (Bradshawhandsanitizer8oz)
Otc - When Using
Stop Use Section (Bradshawhandsanitizer8oz)
Dosage & Administration
Directions: Wet hands thoroughly with product and allow to dry without wiping.
Inactive Ingredient
Inactive Ingredients: Silicon Quaternary Ammonia Salt .75%, Water, Carbomer, Triethanolamine
Warnings
WARNINGS: For external use only
Safe Handling Warning
Flammable: Keep away from open flame. Avoid freezing and excessive heat about 40C.
Other Safety Information
Other information: Non-staining, may discolor certain fabrics.
Indications & Usage
Uses: For handwashing to decrease bacteria on the skin.
When using this product avoid contact with eyes. If contact with eyes occurs, flush with water.
Package Label.Principal Display Panel
Stop Use Section (Bradshawhandsanitizer8oz)
* Please review the disclaimer below.
