Sanihands
FDA Label NDC 80497-001
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynasty Chemical Corp. for the product Sanihands (NDC 80497-001). 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 drug facts, active ingredient, purpose, use, 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
Ethyl Alcohol 65% v/v
Purpose
Sanitary Cleaning
Use
Hand santizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
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 or rash 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 in your palm to thoroughly cover your hands
• Rub hands together briskly until dry
• Children under 6 years of age should be supervised when using this product to avoid swallowing.
Other Information
• Store between 15-30 C (59-86 F)
• Avoid freezing and excessive heat above 40 C (104 F)
Inactive Ingredients:
Water, Polyethylene Glycol, Glycerin USP, Hydrogen Peroxide, Acrylate Polymer, Denatorium Benzoate, Lemon Fragrance
Packaging
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