Otc - Active Ingredient
Active Ingredient: Ethyl Alcohol 70% v/v
Alcohol Agent Sanitizer
FDA Label NDC 58418-159
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 Alcohol Agent Sanitizer (NDC 58418-159). 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 prompt medical attention.
Otc - Purpose
Uses: For handwashing to decrease bacteria on the skin.
Otc - Questions
Questions: 855-647-4647
Dosage & Administration
Directions: Wet hands thoroughly with product and allow to dry without wiping.
Inactive Ingredient
Inactive Ingredients: Water, 3-(Trihydroxysilyl)propyldimethyloctadecyl ammonium chloride
Warnings
WARNINGS For external use only
Safe Handling Warning
Flammable. Keep away from open flame. Do not store above 110F.
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.
* Please review the disclaimer below.
