Active Ingredient:
Ethyl Alcohol at 75%
Frigell Hand Sanitizer
FDA Label NDC 79251-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lenomex, S.a. De C.v. for the product Frigell Hand Sanitizer (NDC 79251-000). 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:, uses:, warnings:, do not use:, when using this product:, stop use and ask 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
Uses:
Hand Sanitizer to help reduce bacteria and germs on skin. For use when soap and water not available.
Warnings:
Flammable. Keep away from fire or open flame and sources of heat or flame.
For external use only.
Do Not Use:
In children less than 2 months of age. On open skin wounds.
When Using This Product:
Keep out of eyes. Do not use in or near the eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly
Stop Use And Ask Doctor:
If irritation or rash appears or occurs. These may be a 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:
Apply a small amount of Frigell in your hand palms and rub hands together and between fingers until dry.
Supervise children under 6 years of age when using this product.
Other Information:
Store below 110°F (43°C). Avoid freezing. May discolor certain fabrics or surfaces.
Inactive Ingredients:
Water (Aqua), Carbomer, Glycerine, Triethanolamine, Benzalkonium Chloride.
Package Labeling:
Bottle (Bottle)
* Please review the disclaimer below.
