Active Ingredient
Ethyl Alcohol 62%
Hand Sanitizer Gel
FDA Label NDC 80524-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tempo Industries, Inc. for the product Hand Sanitizer (NDC 80524-001). 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:, when using this product, stop use and ask a doctor, keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses:
For Hand Sanitizing
Warnings:
For external use only-hands.
Flammable. Keep away from heat and flame.
When Using This Product
- Keep out of eyes. In case of contact with eyes, flush thoroughly with water
- Avoid contact with broken skin.
- Do not inhale or ingest.
Stop Use And Ask A Doctor
If skin irritation develops
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
- Wet hands thoroughly with product and allow to dry without wiping.
- For children under 6 age use only under adult supervision.
- Not recommended for infants
Other Information:
- Do not store above 105°F.
- May discolor some fabrics.
- Harmful to wood finishes and plastics
Inactive Ingredients
Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.
Package Labeling:
Bottle (Bottle)
* Please review the disclaimer below.
