Active Ingredient
Ethyl Alcohol 74% v/v
Foam Hand Sanitizer
FDA Label NDC 80511-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Luxe Decore Sales Ltd. for the product Foam Hand Sanitizer (NDC 80511-002). 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 active ingredient, purpose, uses, warnings, otc - keep out of reach of children, otc - stop use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Ethyl Alcohol 74% v/v................Antiseptic
Uses
highly effective alcohol-based hand sanitizing foam which sanitizes the skin without the need for water.
Warnings
For external use only.
Flammable. Keep away from flame and heat.
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Keep Out Of Reach Of Children
Keep away from children. If swallowed, call a Poison Control Centre or a doctor. Supervise children using this product.
Otc - Stop Use
Stop use and ask a doctor if irritation develops
Directions
Directions ■ adults and children 2 years and older: apply to hands and rub for at least 30 seconds till dry
Other Information
Store below 40°C (100°F).
Inactive Ingredients
water, PEG-10 dimethicone, glycerin
* Please review the disclaimer below.
