POLYSPORIN FIRST AID ANTIBIOTIC- bacitracin and polymyxin b sulfate ointment 
Johnson & Johnson Consumer 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.

----------

Polysporin
First Aid Antibiotic Ointment

Drug Facts

Active ingredients (in each gram)Purpose
Bacitracin 500 units First aid antibiotic
Polymyxin B 10,000 units First aid antibiotic

Uses

first aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Warnings

For external use only

Do not use

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

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

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

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

Other Information

  • Store at 20° to 25°C (68° to 77°F)

Inactive ingredient

white petrolatum base

Questions?

call 800-223-0182

PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton

#1 Dermatologist Recommended
For Infection Protection

Helps prevent infection
in minor cuts, scrapes, and burns
#1
DERMATOLOGIST
RECOMMENDED

Polysporin®
BACITRACIN ZINC • POLYMYXIN B SULFATE
NET WT 1 oz (28.3 g) First Aid Antibiotic Ointment

Principal Display Panel - 28.3 g Tube Carton
POLYSPORIN FIRST AID ANTIBIOTIC 
bacitracin and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-4034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin (UNII: 58H6RWO52I) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58232-4034-61 in 1 CARTON07/09/201311/01/2018
128.3 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:58232-4034-10.9 g in 1 PACKET; Type 0: Not a Combination Product07/09/201311/01/2018
3NDC:58232-4034-21 in 1 CARTON07/09/201311/01/2018
314.2 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:58232-4034-9144 in 1 CARTON07/09/201311/01/2018
40.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B07/09/201311/01/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 12/2016
Document Id: 3dcbde11-6275-498c-9b5e-49fecd29d659
Set id: dd7aceb6-0666-4059-b2a9-8e7fe5f3f0ac
Version: 3
Effective Time: 20161201
 
Johnson & Johnson Consumer Inc.