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 with water.

Stop use and ask doctor:

If irritation or rash appears or occurs. These may be a signs of a seriuous 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 Frïgell 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 110ºF (43ºC). Avoid freezing. May discolor certain fabrics or surfaces.

Inactive Ingredients:

Water (Aqua), Carbomer, Glycerine, Triethanolamine, Benzalkonium Chloride.

Package Labeling: 120ml

Package Labeling: 500ml

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: 79251-000-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
2	NDC: 79251-000-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/20/2020

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