FRIGELL HAND SANITIZER- alcohol gel

Frigell Hand Sanitizer by

Drug Labeling and Warnings

Frigell Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Lenomex, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient:

Ethyl Alcohol at 75%

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:

INGREDIENTS AND APPEARANCE

FRIGELL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79251-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79251-000-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/09/2020

Labeler - Lenomex, S.A. de C.V. (810463562)