POLY BACITRACIN- bacitracin zinc and polymyxin b sulfate ointment 
Phoenix Global Supply Group, 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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Poly Bacitracin

Drug Facts

Active ingredients (each gram contains) Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic

Uses

first aid to help prevent infection in minor:

Warnings

For external use only

Do not use

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

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition persists or gets worse
  • you need to use longer than 1 week
  • 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

Other information

Inactive ingredient

white petrolatum

Questions?

Call 1-877-745-6888

Distributed by:
Phoenix Global Supply Group, Inc.
White Plains, NY 10604

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Poly Bacitracin
Bacitracin Zinc • Polymyxin B Sulfate

First Aid Antibiotic Ointment

NDC 52426-420-06

NET WT 1 oz (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
POLY BACITRACIN 
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52426-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin zinc - UNII:89Y4M234ES) Bacitracin zinc500 [iU]  in 1 g
Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B sulfate10000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52426-420-051 in 1 CARTON
114.2 g in 1 TUBE
2NDC:52426-420-061 in 1 CARTON
228.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B09/23/2010
Labeler - Phoenix Global Supply Group, Inc (843189908)
Establishment
NameAddressID/FEIBusiness Operations
Axellia Pharmaceuticals AS561816174MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Axellia Pharmaceuticals ApS305814345MANUFACTURE

Revised: 9/2010
Document Id: 4a970118-6a7f-4fa1-b822-442a96d20f5b
Set id: 3ff16a04-2060-434b-9f62-38e7a38deb95
Version: 1
Effective Time: 20100928
 
Phoenix Global Supply Group, Inc