73288-005

73288-005
SPL v7
SPL
SPL Set ID 217aa2b8-94f5-468a-99b4-52824a77b573
Route
TOPICAL
Published
Effective Date 2019-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (0.0035 g) Polymyxin B (5000 [USP'U])
Inactive Ingredients
Mineral Oil Water Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-01

Description

Active Ingredient:  Bacitracin Zinc: 400 Units Neomycin Sulfate: 3.5 mg Polymyxin B Sulfate: 5000 Units


Medication Information

Warnings and Precautions

Warnings:

For external use only

Do not use 

  • in eyes
  • over large areas of the bogy
  • if you are allergic to any of the ingredients
  • longer than one week

unless you are directed by the doctor

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition persists ot gets worse
  • a rash or other allergic reaction develops
Indications and Usage

Uses:

First aid to help prevent infections in minor cuts, scrapes, and burns

Dosage and Administration

Directions:

  • Clean the affected area
  • Apply a small amount of this product (the amount equal to the surface area of the tip of a finger) on the area one to three times daily
  • May be covered with a sterile bandage
Description

Active Ingredient:  Bacitracin Zinc: 400 Units Neomycin Sulfate: 3.5 mg Polymyxin B Sulfate: 5000 Units

Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6

Inactive Ingredient

Mineral Oil, Petrplatum, Purified Water

Section 51945-4

Section 55105-1

Purpose: First Aid Antibiotic

Section 55106-9

Active Ingredient: 

Bacitracin Zinc: 400 Units

Neomycin Sulfate: 3.5 mg

Polymyxin B Sulfate: 5000 Units

Section 60561-8

Other information

  • Store at room temperature

Structured Label Content

Indications and Usage (34067-9)

Uses:

First aid to help prevent infections in minor cuts, scrapes, and burns

Dosage and Administration (34068-7)

Directions:

  • Clean the affected area
  • Apply a small amount of this product (the amount equal to the surface area of the tip of a finger) on the area one to three times daily
  • May be covered with a sterile bandage
Warnings and Precautions (34071-1)

Warnings:

For external use only

Do not use 

  • in eyes
  • over large areas of the bogy
  • if you are allergic to any of the ingredients
  • longer than one week

unless you are directed by the doctor

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition persists ot gets worse
  • a rash or other allergic reaction develops
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 51727-6 (51727-6)

Inactive Ingredient

Mineral Oil, Petrplatum, Purified Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: First Aid Antibiotic

Section 55106-9 (55106-9)

Active Ingredient: 

Bacitracin Zinc: 400 Units

Neomycin Sulfate: 3.5 mg

Polymyxin B Sulfate: 5000 Units

Section 60561-8 (60561-8)

Other information

  • Store at room temperature

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)