Pure Gel Hand Sanitizer
FDA Label NDC 79168-435
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by American Textile & Apparel Inc. for the product Pure Gel Hand Sanitizer (NDC 79168-435). 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 drug facts, active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Ethyl Alcohol (70% v/v)
Purpose
Antiseptic
Uses
• Hand sanitizer to help reduce bacteria that potentially can cause disease • For use when soap and water are not available.
Warnings
For external use only
Flammable. Keep away from fire or flames
Do not use
• In children less than 2 months of age • On open skin wounds.
When using this product
• Keep out of eyes, ears, and mouth
• In case of contact with eyes, rinse eyes thoroughly with water
Stop use and ask a doctor if
• Irritation or redness develops. These may be signs of a serious condition
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Place enough product on hands to cover all surfaces • Rub hands together until dry • Supervise children under 6 years of age when using this product to avoid swallowing
Other Information
• Store between 59 – 86° F (15 -30°C)
• Avoid freezing and excessive heat above 104° F (40°C)
Inactive Ingredients
Purified water, glycerin, aculyn excel, triethanolamine.
* Please review the disclaimer below.
