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← See all bacitracin zinc, neomycin sulfate and polymyxin b sulfate brands

bacitracin zinc, neomycin sulfate and polymyxin b sulfate

Medically reviewed on April 18, 2018

Dosage form: ointment
Ingredients: BACITRACIN ZINC 400[iU] in 1g, NEOMYCIN SULFATE 5mg in 1g, POLYMYXIN B SULFATE 5000[iU] in 1g
Labeler: Dynarex Corporation
NDC Code: 67777-217

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.

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

Ask a doctor before use:

First aid to help prevent infection in:

  • Minor cuts
  • scrapes
  • burns

Purpose

First aid to help prevent infection in:

  • Minor cuts
  • scrapes
  • 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

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Warnings

For external use only

Dosage and Administration
  • 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

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

Stop use and ask a doctor if
  • Stop use and ask a doctor if condition persists or gets worse, or if a rash or other allergic reaction occurs

Principal Display panel

Dynarex Triple Antibiotic


triple-antibiotic-ointment-1184-01.jpg

BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-217
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN400 [iU]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:67777-217-0128.35 g in 1 TUBE
2NDC:67777-217-0214.17 g in 1 TUBE
3NDC:67777-217-050.5 g in 1 PACKET
4NDC:67777-217-060.5 g in 1 PACKET
5NDC:67777-217-070.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/01/2009
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Pvt. Ltd.650970176manufacture(67777-217)

 
Dynarex Corporation

← See all bacitracin zinc, neomycin sulfate and polymyxin b sulfate brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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