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Name:Bacitracin
Manufacturer:Qualitest Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


Bacitracin Ointment, USP

BACITRACIN - bacitracin zinc ointment 
Qualitest Pharmaceuticals

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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Bacitracin Ointment, USP

Active ingredient (in each gram)

Bacitracin zinc, USP 500 units

Purpose

First aid antibiotic

Uses

First aid to help reduce the risk of infection in minor:

  • cuts
  • scrapes
  • burns

Warnings

For external use only

Do not use if you are allergic to any of the ingredients

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not use in the eyes
  • do not apply over large areas of the body

Stop use and ask a doctor if

  • you need to use more than 1 week
  • condition persists or gets worse
  • rash or other allergic reaction develops

Keep out of reach of children.

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

Directions

  • clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Other information

  • store at 15°- 30°C (59°- 86°F)
  • lot number and expiration date: See crimp of  tube or box

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

mineral oil, white petrolatum

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 5/10 R5
8260300  0441

PRINCIPAL DISPLAY PANEL

This is an image of the carton for Bacitracin Ointment, USP.

BACITRACIN 
bacitracin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0441
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN ZINC) BACITRACIN ZINC 500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient Name Strength
MINERAL OIL  
PETROLATUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-0441-50 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
1 28.4 g in 1 TUBE This package is contained within the CARTON (0603-0441-50)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333 09/01/2001

Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
Name Address ID/FEI Operations
Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE

Revised: 06/2010 Qualitest Pharmaceuticals



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


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