Zuri 80% Topical Solution Hand Sanitizer
FDA Label NDC 80347-080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kaizen Global Partners Llc for the product Zuri 80% Topical Solution Hand Sanitizer (NDC 80347-080). 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(s), purpose, indications & usage, warnings, otc - 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(S)
Alcohol 80% v/v
Purpose
Antiseptic
Indications & Usage
Use(s) Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
Warnings For external use only. Flammable. Keep away from heat or flame.
Do not use
- On 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 occurs. These may be signs of a serious condition.
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 hand 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 15-30 C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredient
Inactive Ingredients: glycerin, hydrogen peroxide, purified water USP
Packaging
Image (8034708004)
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