BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE  - bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment 
Dynarex Corporation

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Triple Antibiotic Ointment

Active ingredient (in ea. gram)                                                Purpose           
Bacitracin Zinc 400 Units                                                          First Aid Antibiotic

Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)              First Aid Antibiotic

Polymyxin B Sulfate 5000 Units                                                 First Aid Antibiotic

Uses:

First aid to help prevent infection in:

• Minor cuts
• scrapes
  
• burns
  

Warnings:

For external use only

Directions:

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

Stop use and ask a doctor if

•  the condition persists or gets worse, or if a rash or other allergic reaction develops.

Do not use:

• if you are allergic to any of the ingredients
  
• in the eyes
• over large areas of the body
• longer than 1 week unless directed by a doctor
  

Keep out of reach of children

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

Ask a doctor before use:

• in case of deep or puncture wounds
• animal bites
• serious burns
  

Other information

• store at controlled room temperature 15°-30° C (59°-86° F)
• avoid excessive heat and humidity

Inactive ingredients:

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel

Triple Antibiotic Ointment:

BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE  bacitracin zinc, neomycin sulfate and polymyxin b sulfate   ointment

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 67777-217 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (BACITRACIN ZINC) BACITRACIN ZINC 400 [iU]  in 1 g NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 3.5 mg  in 1 g POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 5000 [iU]  in 1 g

Inactive Ingredients Ingredient Name Strength PETROLATUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 67777-217-01 72 TUBE In 1 CASE contains a TUBE 1 28.35 g In 1 TUBE This package is contained within the CASE (67777-217-01) 2 67777-217-02 72 TUBE In 1 CASE contains a TUBE 2 14.17 g In 1 TUBE This package is contained within the CASE (67777-217-02) 3 67777-217-03 72 TUBE In 1 CASE contains a TUBE 3 56.7 g In 1 TUBE This package is contained within the CASE (67777-217-03) 4 67777-217-04 72 TUBE In 1 CASE contains a TUBE 4 113.4 g In 1 TUBE This package is contained within the CASE (67777-217-04) 5 67777-217-05 12 BOX In 1 CASE contains a BOX 5 144 PACKET In 1 BOX This package is contained within the CASE (67777-217-05) and contains a PACKET 5 0.5 g In 1 PACKET This package is contained within a BOX and a CASE (67777-217-05) 6 67777-217-06 1728 PACKET In 1 CASE contains a PACKET 6 0.5 g In 1 PACKET This package is contained within the CASE (67777-217-06) 7 67777-217-07 12 BOX In 1 CASE contains a BOX 7 144 PACKET In 1 BOX This package is contained within the CASE (67777-217-07) and contains a PACKET 7 0.9 g In 1 PACKET This package is contained within a BOX and a CASE (67777-217-07) 8 67777-217-08 1728 PACKET In 1 CASE contains a PACKET 8 0.9 g In 1 PACKET This package is contained within the CASE (67777-217-08) 9 67777-217-09 12 JAR In 1 CASE contains a JAR 9 425.3 g In 1 JAR This package is contained within the CASE (67777-217-09)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333	12/01/2009

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Operations
Galentic Pharma India Private Limited		918531450	manufacture

Revised: 07/2010Dynarex Corporation