Genuine First Aid Antibiotic Ointment

Genuine First Aid Antibiotic Ointment
SPL v1
SPL
SPL Set ID 0aaee474-cf35-8b39-e063-6294a90a815c
Route
TOPICAL
Published
Effective Date 2023-11-21
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 2023-11-01

Description

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5 mg) 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 3.5 mg) 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

Package Labeling:

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.

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 3.5 mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

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

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

Package Labeling:

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.)

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 3.5 mg)

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 bums

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)