FDA.reportPublic FDA data

Globe Triple Antibiotic Ointment

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2023-07-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:29:08

Label at a glance#

ProductTriple Antibiotic
Active ingredientPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, BACITRACIN ZINC
Label structure18 sections

Indications and uses

First Aid to help prevent infection in minor: cuts scrapes burns

Dosage and administration

Clean the affected area and dry thoroughly Apply a small amount of the 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

Storage and handling

Store at 20° to 25°C (68° to 77°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zinc 400 Units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Neomycin 3.5 mg

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Polymyxin B Sulfate 5000 Units

Purpose

OTC - PURPOSE SECTION

First Aid Antibiotic

Uses

INDICATIONS & USAGE SECTION

First Aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For External Use Only.

Ask Doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds

animal bites

serious burns

Do Not Use

OTC - DO NOT USE SECTION

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

Stop Use and Ask Doctor if

OTC - STOP USE SECTION

  • If you need to use longer than 1 week
  • The condition persists or gets worse
  • A rash or allergic reaction develops

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area and dry thoroughly
  • Apply a small amount of the 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

mineral oil and petrolatum

Questions

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Fax: 1-888-878-3609

Online: www.trifecta-pharma.com

Reorder No. 1012SL

Storage Information

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F).

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Other Information

SPL UNCLASSIFIED SECTION

Distributed By:

Trifecta Pharmaceuticals USA®

Ft. Lauderdale, FL. 33301 USA

Made in USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

globe-triple-antibiotic-CDERglobe-triple-antibiotic-CDER

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-06269396-062-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
POLYMYXIN B SULFATE19371312D4ACTIM
NEOMYCIN SULFATE057Y626693ACTIM
BACITRACIN ZINC89Y4M234ESACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ffc092b2-b835-c91b-e053-6394a90a3a06a7bfa4b5-72b7-334a-e053-2a95a90aed3d2023-07-05WarningsExact identifier
spl id: ffc092b2-b835-c91b-e053-6394a90a3a06
spl set id: a7bfa4b5-72b7-334a-e053-2a95a90aed3d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.