Tribiotic-lc

Tribiotic-lc
SPL v1
SPL
SPL Set ID b5725d7a-2a46-415a-9b90-33dd52439217
Route
TOPICAL
Published
Effective Date 2012-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 1) Neomycin (5 mg) Polymyxin B (5000 1) Lidocaine (40 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-05-04

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 Lidocaine 40mg


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 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 Lidocaine 40mg

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
  • symptoms clear up and occur again within a few days



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
  • in large quantities, particularly over raw surfaces or blistered areas

  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily
Section 51727-6

Petrolatum

Section 51945-4

tribioticlc.jpg

Section 55105-1

Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic

Topical Anesthetic

Section 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

Lidocaine 40mg


Structured Label Content

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

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.

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
  • symptoms clear up and occur again within a few days



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
  • in large quantities, particularly over raw surfaces or blistered areas

  • 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)

tribioticlc.jpg

Section 55105-1 (55105-1)

Purpose:

Topical Antibiotic

Topical Antibiotic

Topical Antibiotic

Topical Anesthetic

Section 55106-9 (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

Lidocaine 40mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)