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Name:Berkley And Jensen Triple Antibiotic
Manufacturer:Bjwc
Category:Over-the-counter (OTC) Marketed Drugs


BJWC Triple Antibiotic Ointment Drug Facts

BERKLEY AND JENSEN TRIPLE ANTIBIOTIC - bacitracin, neomycin sulfate and polymyxin b sulfate ointment 
BJWC

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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BJWC Triple Antibiotic Ointment Drug Facts

Active ingredient (in each gram)

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5,000 units

Purpose

First aid antibiotic

Uses

first aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Warnings

For external use only

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer 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 20°-25°C (68°-77°F)

Inactive ingredients

light mineral oil, white petrolatum

Questions or comments?

1-800-934-1204

Principal Display Panel

Original Strength

Triple Antibiotic Ointment

Bacitracin

Neomycin Sulfate

Polymyxin B Sulfate

First Aid Antibiotic Ointment

Triple Antibiotic Ointment Carton

Triple Antibiotic Ointment Carton


BERKLEY AND JENSEN TRIPLE ANTIBIOTIC 
bacitracin, neomycin, polymyxin b ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68391-067
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN (BACITRACIN) BACITRACIN 400 [USP'U]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 5000 [USP'U]  in 1 g
Product Characteristics
Color WHITE (Translucent) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68391-067-16 2 TUBE ( TUBE) in 1 CARTON contains a TUBE (68391-067-64)
1 NDC:68391-067-64 28 g in 1 TUBE This package is contained within the CARTON (68391-067-16)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 12/16/2008

Labeler - BJWC (159082692)

Revised: 05/2009 BJWC



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


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