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Name:Bortons Ethyl Rubbing Alcohol
Manufacturer:J-mark International Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Borton's Ethyl Rubbing Alcohol

BORTONS ETHYL RUBBING ALCOHOL  - alcohol liquid 
J-Mark International Inc.

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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Borton's Ethyl Rubbing Alcohol

Drug Facts

Active Ingredients                        Purpose

Ethyl Alcohol 82 percent            Antiseptic

Uses

First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

Warnings

Flammable. Keep away from fire or flame. For external use only. Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

Clean the affected area. Apply a small amount of this product on the area 1 ti 3 times daily. May be covered with a sterile bandage.

Inactive Ingredients

Camphor, Water

Other Information

For your protection, this bottle has an imprinted seal around the cap. Do not use if tamper evident seal is missing, tampered, broken, or destroyed.

Distributed by/Distribuido por

J-MARK International Inc.

0819-03925

Panama



Made In/Hecho en Panama

Expiration Date/Fecha de Expiracion 12/20/15

Borton's ETHYL RUBBING ALCOHOL 82 percent By Volume FIRST AID ANTISEPTIC Net Contents 16 fl oz (473 ml)

FrontLabel

BackLabel

BORTONS ETHYL RUBBING ALCOHOL 
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50790-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 82 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50790-100-16 473 mL in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 04/30/2010

Labeler - J-Mark International Inc. (853770001)
Registrant - J-Mark International Inc. (853770001)
Establishment
Name Address ID/FEI Operations
J-Mark International Inc. 853770001 manufacture

Revised: 05/2010 J-Mark International Inc.



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


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