EL BUENO- ethyl alcohol gel

EL BUENO by

Drug Labeling and Warnings

EL BUENO by is a Otc medication manufactured, distributed, or labeled by Fiesta Unión, S. de R. L. de C.V., Ecodeli Comercial SA de CV, Fiesta Union S de RL de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Warnings

For external use only. Flammable. Keep away from heat or flame

Inactive ingredients

Water, propylene glycol, glycerin, polyacrylic acid, and triethanolamine

INDICATIONS & USAGE

Health care personnel hand rub to help reduce that potentially can cause disease

Keep out of reach of children

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

Purpose

Hand sanitizer. Antiseptic

Active Ingredient(s)

Ethyl alcohol 75% v/v

Stop use and ask a doctor

If irritation or rash occurs. These may be signs of a serious condition.

Do not use

In children less than 2 months of age.

on open skin wounds.

PRINCIPAL DISPLAY PANEL

1000 mL NDC: 75719-001-01

INGREDIENTS AND APPEARANCE

EL BUENO 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75719-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)	0.3 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	3 mL  in 100 mL
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	20.2 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75719-001-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/04/2020

Labeler - Fiesta Unión, S. de R. L. de C.V. (812828282)

Registrant - Fiesta Unión, S. de R. L. de C.V. (812828282)

Establishment
Name	Address	ID/FEI	Business Operations
Ecodeli Comercial SA de CV		588530951	manufacture(75719-001)

Establishment
Name	Address	ID/FEI	Business Operations
Fiesta Union S de RL de CV		812828282	relabel(75719-001)