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

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

Stop use and ask a doctor if

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

Indications and Usage

  • 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

Purpose

First aid to help prevent infection in:
Minor cuts
scrapes
burns

Ask a doctor before use:


Other information

Inactive ingredients:

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel

Triple Antibiotic Ointment:

triple_antibiotic.jpg

triple_antibiotic

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:63777-217
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63777-217-0128.35 g in 1 TUBE
2NDC:63777-217-0214.17 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/15/2010
Labeler - Kinray Inc. (012574513)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma India Private Limited918531450manufacture(63777-217)

Revised: 1/2014
Document Id: 3e9027ac-cfdd-448b-a8e3-9f9f48babd81
Set id: 26898f51-a855-47e5-95d0-5ad9673b6236
Version: 5
Effective Time: 20140121
 
Kinray Inc.