Active Ingredient(S)
Alcohol 70% v/v
Hand Sanitizer
FDA Label NDC 83584-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Purcel Labs Llc for the product Hand Sanitizer (NDC 83584-016). 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(s), purpose, uses, wamings, do not use, otc - when using, otc - stop use, otc - 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
Uses
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Wamings
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.
Otc - When Using
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Otc - Stop Use
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
• Put enough product in your palm to cover hands and rub hands together briskly until dry.
• Children under 6 years of age should be supervised when using products.
Other Information
• Store below 110°F (43°C).
• Avoid freezing and excessive heat above 104°F (40°C).
• May discolor certain fabrics or surfaces.
Inactive Ingredients
Aloe Vera, Carbomer Interpolymer (type B)，Lemon oil， Glycerin, Triethanolamine, Water (Aqua).
* Please review the disclaimer below.
