Active Ingredient
Ethyl Alcohol 70% v/v
Hand Sanitizer
FDA Label NDC 80981-110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Johnny Was for the product Hand Sanitizer (NDC 80981-110). 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, use(s), warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Use(S)
Hand Sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame.
Do Not Use
in children under 2 months of age
on open 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.
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 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 Ingredients
Acrylates Copolymer, Aminomethyl Propanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Ethyl Palmate, Fragrance, Glycerin, Water
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