BACTEX ANTISEPTIC HAND SANITIZER- alcohol gel

BACTEX Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

BACTEX Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Punto Rojo, S.A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredient                                Purpose

Ethyl Alcohol 62 percent                  Antimicrobial

PURPOSE

Uses for hand washing to decrease bacteria on the skin.

WARNINGS

Warnings

Flammable, keep away from fire or flame

For external use only

Do not use in the eyes

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Keep out of the reach of children.

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

DOSAGE & ADMINISTRATION

Directions:

Wet hands thoroughly with product and allow to dry without wiping.

INACTIVE INGREDIENT

Inactive Ingredients:

Deionized water, Propylene Glycol, Glycerol Ethoxylate, Triethanolamine

QUESTIONS

Questions or Comments

Call: 506 2442 04848

Write to: Departamento de Mercadeo

Apartado 344-4050 Alajuela, Costa Rica

www.puntorojo.com

Email: informacion@puntorojo.com

DESCRIPTION

Manufactured By:

Punto Rojo S.A.

200 Metros Norte de

los Tribunales de Justicia

Alajuela, 160-4050

Costa Rica

PRINCIPAL DISPLAY PANEL

BACTEX
Antibacterial

Antiseptic
Hand Sanitizer

NO WATER REQUIRED 
FAST ACTING

Product Of Costa Rica

Kills 99.9 percent of Germs

Net Contents 2.7 Oz.

QUESTIONS

INGREDIENTS AND APPEARANCE

BACTEX ANTISEPTIC HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49839-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49839-200-10	80 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	11/01/2009

Labeler - Punto Rojo, S.A (853018687)

Registrant - Punto Rojo, S.A (853018687)

Establishment
Name	Address	ID/FEI	Business Operations
Punto Rojo, S.A		853018687	manufacture