EL BUENO- isopropyl 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., Fiesta Union S de RL de CV, INOVAKER LAB S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, trolamine, fragrance, polyacrylic acid, glycerin

Package Label - Principal Display Panel

250 ml NDC: 75719-002-02

INGREDIENTS AND APPEARANCE

EL BUENO 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75719-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	0.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	21.5 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.4 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75719-002-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/07/2020

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
Fiesta Union S de RL de CV		812828282	relabel(75719-002)

Establishment
Name	Address	ID/FEI	Business Operations
INOVAKER LAB S.A. DE C.V.		951577122	manufacture(75719-002)