Pure Usa Hand Sanitizer
FDA Label NDC 80665-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pure Usa, Llc for the product Pure Usa Hand Sanitizer (NDC 80665-101). 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, indications & usage, otc - keep out of reach of children, directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Ethyl Alcohol 80% v/v
Purpose
Antiseptic
Indications & Usage
Use Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Otc - Keep Out Of Reach Of Children
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 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
Inactive ingredients glycerin, hydrogen peroxide, purified water USP, fragrance
Packaging
Image (8065510175)
Image (8065510115)
Image (8065510103)
Image (Boximage)
Image (Drugfactslb)
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