Triple Antibiotic Ointment Label

Triple Antibiotic Ointment Label
SPL v2
SPL
SPL Set ID 31185e4c-b1fd-4ea1-b648-971ef6a1f3bc
Route
TOPICAL
Published
Effective Date 2010-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin Zinc (500 [iU]) Neomycin (3.5 mg) Polymyxin B (10000 [iU])
Inactive Ingredients
Tea Tree Oil Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 1995-07-01

Description

Active Ingredients (each gram contains:) Bacitracin zinc 500 units Neomycin 3.5 mg Polymyxin B sulfate 10,000 units


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

Uses

First aid to help prevent the risk of infection in minor

  • cuts
  • scrapes
  • burns

Dosage and Administration

Directions

  • Clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1-3 times daily
  • may be covered with a sterile bandage

Description

Active Ingredients (each gram contains:) Bacitracin zinc 500 units Neomycin 3.5 mg Polymyxin B sulfate 10,000 units

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops

Section 50569-3

Ask a doctor

before use
in case of deep or puncture wounds, animal bites, or serious burns

Section 50570-1

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than one week unless directed by a doctor
Section 51727-6

Inactive ingredients:  Melaleuca Oil (T36-C5(R)), mineral oil, petrolatum

Section 51945-4

Section 55105-1

Purpose

antibiotic

Section 55106-9

Active Ingredients (each gram contains:)

Bacitracin zinc 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units


Structured Label Content

Indications and Usage (34067-9)

Uses

First aid to help prevent the risk of infection in minor

  • cuts
  • scrapes
  • burns

Dosage and Administration (34068-7)

Directions

  • Clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1-3 times daily
  • may be covered with a sterile bandage

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops

Section 50569-3 (50569-3)

Ask a doctor

before use
in case of deep or puncture wounds, animal bites, or serious burns

Section 50570-1 (50570-1)

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than one week unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients:  Melaleuca Oil (T36-C5(R)), mineral oil, petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

antibiotic

Section 55106-9 (55106-9)

Active Ingredients (each gram contains:)

Bacitracin zinc 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units


Advanced Ingredient Data


Raw Label Data

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