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


triple_antibiotic



BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63777-217
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN ZINC) BACITRACIN ZINC400 [iU]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63777-217-0172 in 1 CASE
128.35 g in 1 TUBE
2NDC:63777-217-0272 in 1 CASE
214.17 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33304/15/2010
Labeler - Kinray Inc. (012574513)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma India Private Limited918531450manufacture

Revised: 4/2010
Document Id: 9353bc87-c83c-42c8-abde-422bfff161e5
Set id: 26898f51-a855-47e5-95d0-5ad9673b6236
Version: 3
Effective Time: 20100426
 
Kinray Inc.