POLYSPORIN- polymyxin b sulfate and bacitracin zinc powder 
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®
Bacitracin Zinc • Polymyxin B Sulfate
First Aid Antibiotic Powder

Drug Facts

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

Use

first aid to help prevent infection in minor:

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

Other information

Inactive ingredient

lactose base

Questions?

call 1-800-223-0182

PRINCIPAL DISPLAY PANEL - 10g Bottle Label

#1
DERMATOLOGIST
RECOMMENDED

Polysporin®

BACITRACIN ZINC • POLYMYXIN B SULFATE
First Aid Antibiotic Powder

Helps prevent infection in minor cuts, scrapes, and burns

NET WT 0.35 oz (10g)

Principal Display Panel - 10g Bottle Label
POLYSPORIN 
polymyxin b sulfate and bacitracin zinc powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-4033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58232-4033-11 in 1 CARTON06/14/201012/01/2023
110 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B06/14/201012/01/2023
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 5/2019
Document Id: 2e5e2017-0a31-4282-b21d-1b4ab0e3e544
Set id: 0b0c5a93-4a2a-45dc-9800-55c914369b63
Version: 2
Effective Time: 20190507
 
Johnson & Johnson Consumer Inc.