TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment 
Topco Associates LLC

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

Drug Facts

Active ingredients (in each gram)Purpose
Bacitracin zinc USP 400 unitsFirst aid antibiotic
Neomycin sulfate USP 3.5 mgFirst aid antibiotic
Polymyxin B sulfate USP 5,000 unitsFirst aid antibiotic

Uses

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 ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

Questions?

Call 1-888-423-0139

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

TopCare®
health

ORIGINAL STRENGTH

• OUR PHARMACISTS
RECOMMEND •

Triple Antibiotic Ointment
BACITRACIN ZINC, NEOMYCIN SULFATE & POLYMYXIN B SULFATE
First Aid Antibiotic Ointment

NET WT 1 OZ (28.4 g)

NDC 36800-564-02

Principal Display Panel - 28.4 g Tube Carton
TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-564
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
cocoa butter (UNII: 512OYT1CRR)  
cottonseed oil (UNII: H3E878020N)  
olive oil (UNII: 6UYK2W1W1E)  
sodium pyruvate (UNII: POD38AIF08)  
.alpha.-tocopherol (UNII: H4N855PNZ1)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-564-011 in 1 CARTON11/30/2016
114.2 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:36800-564-021 in 1 CARTON11/30/2016
228.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B12/15/2015
Labeler - Topco Associates LLC (006935977)

Revised: 4/2019
Document Id: 760114cb-d1ec-4cff-bac7-d42b82098545
Set id: 55a8a52c-4d03-417d-9283-406f6879bcb5
Version: 3
Effective Time: 20190404
 
Topco Associates LLC