Otc - Active Ingredient
Alcohol 75% v/v. Purpose: Antiseptic
Purfree Hand Sanitizer
FDA Label NDC 78717-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sterilco Sp Z O O for the product Purfree Hand Sanitizer (NDC 78717-001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - 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
Otc - Purpose
Antiseptic, Hand Sanitizer
Indications & Usage
to help reduce bacteria on the skin. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from sources of heat or fire.
Otc - Do Not Use
-on children less than 2 months of age.
-on open skin wounds.
Otc - When Using
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop using and ask a doctor if irritation or redness develops and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
-put enough product in your palm to cover hands and rub hands together until dry.
-children under 6 years old should be supervised when using this product.
Storage And Handling
-store at a temperature below 110°F (43°C).
-may discolor certain fabrics and surfaces.
Inactive Ingredient
water, Glycerin, Propylene Glycol, Menthol, Carbomer, Aminomethyl Propanol.
Package Label.Principal Display Panel
473 mL NDC: 78717-001-01
NDC: 78717-001-02
* Please review the disclaimer below.
