First Aid Antibiotic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

First Aid Antibiotic Ointment Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
SPL v1
SPL
SPL Set ID c6f2656e-b822-4d61-b557-dd2046dd51f5
Route
TOPICAL
Published
Effective Date 2024-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 U) Neomycin (3.5 mg) Polymyxin B (5000 U)
Inactive Ingredients
Mineral Oil Petrolatum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-15

Description

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic


Medication Information

Purpose

First aid antibiotic

Description

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5mg) Polymyxin B sulfate (polymyxin B 5,000 units)

Use
  • First aid to help prevent infection in minor cuts,scrapes and burns.
Question?

+1(855)924-2182

Warnings:

For external use only. 

Do Not Use
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor.
Drug Facts

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 to 3 times daily.
  • May be covered with a sterile bandage.
Other Information:

Store at room temperature

Package Labelling:

Inactive Ingredient:

Mineral oil, petrolatum, purified water

Stop Use and Ask A Doctor If
  • the condition persists or gets worse.
  • a rash or other allergic reaction develops.
Keep Out of Reach of Children.

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

Active Ingredients (in Each Gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Ask A Doctor Before Use If You Have
  • deep or puncture wounds 
  • animal bites 
  • serious burns

Structured Label Content

Use
  • First aid to help prevent infection in minor cuts,scrapes and burns.
Purpose

First aid antibiotic

Question?

+1(855)924-2182

Warnings:

For external use only. 

Do Not Use (Do not use)
  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor.
Drug Facts

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 to 3 times daily.
  • May be covered with a sterile bandage.
Other Information: (Other information:)

Store at room temperature

Package Labelling:

Inactive Ingredient: (Inactive ingredient:)

Mineral oil, petrolatum, purified water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition persists or gets worse.
  • a rash or other allergic reaction develops.
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds 
  • animal bites 
  • serious burns

Advanced Ingredient Data


Raw Label Data

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