IVGEL HAND SANITIZER- alcohol gel

Ivgel Hand Sanitizer by

Drug Labeling and Warnings

Ivgel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IVGEL Drug Fact Chart

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Active Ingredients:

Ethyl Alcohol at 70%

Purpose:

Antiseptic

Uses:

Hand Sanitizer to help reduce germs. For use when soap and water not available.

Warning:

For external use only, Flammable. Keep away from open flame and sources of heat or flame.

Do not use:

In children less than 2 months of age. On open skin wounds.

When using this product:

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask doctor:

If irritation or rash occurs. These may be 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 product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing

Other information:

Store below 110°F (43°C). Avoid freezing. May discolor certain fabrics or surfaces.

Inactive Ingredients:

Water, Glycerine, Carbopol, Triethanolamine.

Package Labeling:

INGREDIENTS AND APPEARANCE

IVGEL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74967-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74967-000-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/15/2020

Labeler - VAGO INTERNACIONAL MANUFACTURING, S.A. DE C.V. (589993745)