First Aid Only Triple Antibiotic Ointment

First Aid Only Triple Antibiotic Ointment
SPL v2
SPL
SPL Set ID f9a48f73-aa12-cf68-e053-6294a90a8e53
Route
TOPICAL
Published
Effective Date 2023-04-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Neomycin (3.5 mg) Polymyxin B (5000 [iU])
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-24

Description

Drug Facts

Purpose

First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out the reach of children.

Section 51945-4

Box Label

Warnings

For external use only

Questions

1-800-835-2263

Directions
  • Clean the affected area.
  • Apply a small amount of product 1 to 3 times daily
  • may be covered with a sterile bandage
Do Not Use
  • in the eyes
  • over large areas of the body
  • on puncture wounds, animal bites, or serious burns
  • longer than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients
Inactive Ingredient

White Petrolatum

Stop Use and Ask A Doctor If:
  • a rash or allergic reaction develops
  • condition worsens or persists

Active Ingredient (in Each Gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin Sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out the reach of children.

Section 51945-4 (51945-4)

Box Label

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Warnings

For external use only

Questions

1-800-835-2263

Directions
  • Clean the affected area.
  • Apply a small amount of product 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
  • on puncture wounds, animal bites, or serious burns
  • longer than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients
Inactive Ingredient

White Petrolatum

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • a rash or allergic reaction develops
  • condition worsens or persists

Active Ingredient (in Each Gram) (Active Ingredient (in each gram))

Bacitracin Zinc (400 units Bacitracin)

Neomycin Sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate (Polymyxin B 5000 units)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)