tribiotic

tribiotic
SPL v5
SPL
SPL Set ID d8f175f9-f526-4c73-a171-49309ca16cb0
Route
topical
Published
Effective Date 2024-01-18
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
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2005-10-03

Description

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


Medication Information

Warnings and Precautions

Warnings: For external use only

Serious burns require immediate medical attention

Active Ingredient

Active Ingredients (in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5mg neomycin base)

Polymyxin B Sulfate 5,000 units

Indications and Usage

Uses: First aid to help prevent infection and temporarily relieve pain 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 400 units Neomycin Sulfate 5 mg (equivalent to 3.5mg neomycin base) Polymyxin B Sulfate 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.

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

Petrolatum

Section 51945-4

Section 55105-1

Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic


Structured Label Content

Warnings and Precautions (34071-1)

Warnings: For external use only

Serious burns require immediate medical attention

Active Ingredient (55106-9)

Active Ingredients (in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5mg neomycin base)

Polymyxin B Sulfate 5,000 units

Indications and Usage (34067-9)

Uses: First aid to help prevent infection and temporarily relieve pain 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

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.

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)

Petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)