HAND SANITIZER- alcohol gel

Hand sanitizer by

Drug Labeling and Warnings

Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Industrias Trevigo, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient:

Ethyl Alcohol 70%

Purpose:

Antimicrobial

Use:

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

+ Flammable --- Keep away from fire or flame.
+ For external use only.

When using this product

 + do not use in or near the eyes. In case of contact, rinse eyes throughly with water.

Stop use and ask a doctor

+ if irritation or rash appears and lasts.

Keep out of reach of children.

+ If swallowed, get medical help or contact a Poison Control Center right away.

Directions

+ Place product on hands.
+ Rub until dry.

Inactive ingredients:

Water, Carbomer, Glycerin, T.E.A, Benzalkonium chloride, Fragrance ( Parfum ).

Other Information

+ Store below 110ºC ( 43ºF )
+ May discolor certain fabrics or surfaces.

Package Labeling: 236ml

Package Labeling: 473ml

Package Labeling: 1L

Package Labeling: 3.78L

Package Labeling: 1000L

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79409-000
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)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79409-000-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2019
2	NDC: 79409-000-02	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2019
3	NDC: 79409-000-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2019
4	NDC: 79409-000-04	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2019
5	NDC: 79409-000-05	1000000 mL in 1 TANK; Type 0: Not a Combination Product	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/01/2019

Labeler - Industrias Trevigo, S.A. de C.V. (589602580)

Establishment
Name	Address	ID/FEI	Business Operations
Industrias Trevigo, S.A. de C.V.		589602580	manufacture(79409-000) , label(79409-000) , pack(79409-000) , transfill(79409-000)