Tribiotic

Tribiotic
SPL v1
SPL
SPL Set ID c1903b9f-390a-4756-800c-fd93be4182e3
Route
TOPICAL
Published
Effective Date 2025-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Neomycin (3.5 mg) Polymyxin B (5000 [iU])
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-13

Description

Active Ingredients (in each gram) Bacitracin Zinc (bacitracin 400 units) Neomycin Sulfate (neomycin 3.5mg)  Polymyxin B Sulfate (polymyxin B 5,000 units)


Medication Information

Warnings and Precautions

Warnings: For external use only

Serious burns require immediate medical attention

Indications and Usage

Uses: First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
  • abrasions
Dosage and Administration

Directions:

Do not use more than directed.

Adults and children 12 years of age and over:

  • clean the affected area
  • apply 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

Children under 12 years of age: ask a doctor

Description

Active Ingredients (in each gram) Bacitracin Zinc (bacitracin 400 units) Neomycin Sulfate (neomycin 3.5mg)  Polymyxin B Sulfate (polymyxin B 5,000 units)

Section 34084-4

Allergy alert: Do not use if you are allergic to any of the ingredients

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9

Stop use and ask a doctor if

  • condition worsens or lasts for more than 7 days
  • a rash or other allergic reaction occurs

Section 50569-3

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns
Section 50570-1

do not use

  • in or near the eyes
  • over large portions of the body
  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily
Section 51727-6

White Petrolatum

Section 51945-4

Section 55105-1

Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic

Section 55106-9

Active Ingredients (in each gram)

Bacitracin Zinc (bacitracin 400 units)

Neomycin Sulfate (neomycin 3.5mg) 

Polymyxin B Sulfate (polymyxin B 5,000 units)

Other Information
  • avoid excessive heat
  • ointment enclosed in a sealed packet
  • do not use if packet is torn, cut or open
  • store at 59° to 86°F (15°-30°C)

Structured Label Content

Indications and Usage (34067-9)

Uses: First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
  • abrasions
Dosage and Administration (34068-7)

Directions:

Do not use more than directed.

Adults and children 12 years of age and over:

  • clean the affected area
  • apply 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

Children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings: For external use only

Serious burns require immediate medical attention

Section 34084-4 (34084-4)

Allergy alert: Do not use if you are allergic to any of the ingredients

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens or lasts for more than 7 days
  • a rash or other allergic reaction occurs

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns
Section 50570-1 (50570-1)

do not use

  • in or near the eyes
  • over large portions of the body
  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily
Section 51727-6 (51727-6)

White Petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic

Section 55106-9 (55106-9)

Active Ingredients (in each gram)

Bacitracin Zinc (bacitracin 400 units)

Neomycin Sulfate (neomycin 3.5mg) 

Polymyxin B Sulfate (polymyxin B 5,000 units)

Other Information
  • avoid excessive heat
  • ointment enclosed in a sealed packet
  • do not use if packet is torn, cut or open
  • store at 59° to 86°F (15°-30°C)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)