First Aid Antibiotic Ointment

First Aid Antibiotic Ointment
SPL v4
SPL
SPL Set ID 34e8776c-1f36-4e1b-9d71-727591ac904d
Route
TOPICAL
Published
Effective Date 2022-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Neomycin (35 mg) Polymyxin B (5000 [iU])
Inactive Ingredients
Mineral Oil Petrolatum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-11-01 Until 2027-04-01

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.
Warnings

For external use only.

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.
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

Other Information

Store at room temperature

Inactive Ingredients

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.

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

Package Labeling: 82996 001 01

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

Warnings

For external use only.

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.
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

Other Information (Other information)

Store at room temperature

Inactive Ingredients (Inactive ingredients)

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.)

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

Package Labeling: 82996 001 01 (Package Labeling: 82996-001-01)

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

All Sections (JSON)