Triple Antibiotic First Aid Antibiotic Ointment

Triple Antibiotic First Aid Antibiotic Ointment
SPL v4
SPL
SPL Set ID 78f00296-267b-44c3-a9e3-c40f122e905e
Route
TOPICAL
Published
Effective Date 2020-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (3.5 mg) Polymyxin B (5000 [USP'U])
Inactive Ingredients
Cocoa Butter Cottonseed Oil Olive Oil Sodium Pyruvate .alpha.-tocopherol Acetate White Petrolatum Paraffin Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-12-09

Description

Active Ingredients Bacitracin Zinc 400U Neomycin 3.5 mg Polymyxin B Sulfate 5000U


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Dosage and Administration

Directions

  • Clean the affected area and dry thoroughly
  • May be covered with a sterile bandage
  • Apply a 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
Description

Active Ingredients Bacitracin Zinc 400U Neomycin 3.5 mg Polymyxin B Sulfate 5000U

Section 42229-5

Other Information

  • Store at 20°C to 25°C (68°F to 77°C)
  • Lot No. & Exp. Date: see crimp of tube
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 consult a doctorif the condition persists or gets worse, or if a rash or other allergic reaction develops

Section 50569-3

Ask a doctor before use on

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

Do not use

  • in the eyes
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
  • over large areas of the body
Section 51727-6

Inactive Ingredients

cocoa butter, cotton seed oil, olive oil,  sodium pyruvate, vitamin E, white petrolatum, hard parrafin, mineral oil

Section 51945-4

PRINCIPAL DISPLAY PANEL

Triple Antibiotic First Aid Antibiotic Ointment

NET WT 0.5 OZ (14 g)

Section 55105-1

Purpose

First Aid Antibiotic

Section 55106-9

Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U


Structured Label Content

Indications and Usage (34067-9)

Uses

first aid to help prevent infection in

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

Directions

  • Clean the affected area and dry thoroughly
  • May be covered with a sterile bandage
  • Apply a 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
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Other Information

  • Store at 20°C to 25°C (68°F to 77°C)
  • Lot No. & Exp. Date: see crimp of tube
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 consult a doctorif the condition persists or gets worse, or if a rash or other allergic reaction develops

Section 50569-3 (50569-3)

Ask a doctor before use on

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

Do not use

  • in the eyes
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
  • over large areas of the body
Section 51727-6 (51727-6)

Inactive Ingredients

cocoa butter, cotton seed oil, olive oil,  sodium pyruvate, vitamin E, white petrolatum, hard parrafin, mineral oil

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

Triple Antibiotic First Aid Antibiotic Ointment

NET WT 0.5 OZ (14 g)

Section 55105-1 (55105-1)

Purpose

First Aid Antibiotic

Section 55106-9 (55106-9)

Active Ingredients

Bacitracin Zinc 400U

Neomycin 3.5 mg

Polymyxin B Sulfate 5000U


Advanced Ingredient Data


Raw Label Data

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