TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment 
Taro Pharmaceuticals U.S.A., 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

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

  • 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 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Triple Antibiotic
Ointment

Original Strength

Bacitracin Zinc USP • Neomycin Sulfate USP • Polymyxin B Sulfate USP

First Aid Antibiotic Ointment

NET WT 1 oz (28.4 g)

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:51672-2016
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:51672-2016-11 in 1 CARTON12/14/1995
114.2 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51672-2016-21 in 1 CARTON12/14/1995
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 FINALpart333B12/14/1995
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2016)

Revised: 1/2020
Document Id: 34f19b6e-8d34-4f3c-80ec-34d81ee6e044
Set id: 33045ad1-a3b4-44a0-a50f-6754ed231f71
Version: 3
Effective Time: 20200131
 
Taro Pharmaceuticals U.S.A., Inc.