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Name:Bactex Antiseptic Hand Sanitizer
Manufacturer:Punto Rojo, S.a
Category:Over-the-counter (OTC) Marketed Drugs


BACTEX Antibacterial Antiseptic Hand Sanitizer

BACTEX ANTISEPTIC HAND SANITIZER  - alcohol gel 
Punto Rojo, S.A

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BACTEX Antibacterial Antiseptic Hand Sanitizer

Drug Facts

Active Ingredient                                Purpose

Ethyl Alcohol 62 percent                  Antimicrobial

Uses for hand washing to decrease bacteria on the skin.

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.

Directions:

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

Inactive Ingredients:

Deionized water, Propylene Glycol, Glycerol Ethoxylate, Triethanolamine

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

Manufactured By:

Punto Rojo S.A.

200 Metros Norte de

los Tribunales de Justicia

Alajuela, 160-4050

Costa Rica


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.

BactexHandSanitizer

BACTEX ANTISEPTIC HAND SANITIZER 
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49839-200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 62 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
PROPYLENE GLYCOL  
TROLAMINE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49839-200-10 80 mL in 1 BOTTLE None

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 Operations
Punto Rojo, S.A 853018687 manufacture

Revised: 10/2009 Punto Rojo, S.A



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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