Triple Antibiotic Ointment (bacitracin Zinc, Neomycin Sulfate, Polymyxin b Sulfate)

Triple Antibiotic Ointment (bacitracin Zinc, Neomycin Sulfate, Polymyxin b Sulfate)
SPL v1
SPL
SPL Set ID 32df5cca-77bc-45d2-b1f6-2cfdfc371ea9
Route
TOPICAL
Published
Effective Date 2025-01-28
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (3.5 mg) Polymyxin B (5000 [USP'U])
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-29

Description

Active Ingredient  (in each gram) Bacitracin Zinc, USP            400 units Neomycin                             3.5mg  Polymyxin B Sulfate, USP   5,000 units

Purpose

First aid antibiotic


Medication Information

Purpose

First aid antibiotic

Description

Active Ingredient  (in each gram) Bacitracin Zinc, USP            400 units Neomycin                             3.5mg  Polymyxin B Sulfate, USP   5,000 units

Use(s)

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • 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
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Other Information

■ store at 15°-30°C (59°-86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredient

white petrolatum

Active Ingredient(s)

Active Ingredient (in each gram)

Bacitracin Zinc, USP            400 units

Neomycin                             3.5mg 

Polymyxin B Sulfate, USP   5,000 units

Questions Or Comments?

Call 1-833-285-4151 Monday-Friday 9AM-5PM EST

Principal Display Panel
Stop Use and Ask A Doctor If

■ you need to use longer than one week

■ condition persists or gets worse

■ rash or other allergic reaction develops

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have

■ deep or puncture wounds

■ animal bites

■ serious burns


Structured Label Content

Use(s) (USE(S))

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns
Purpose (PURPOSE)

First aid antibiotic

Warnings (WARNINGS)

For external use only.

Directions (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)
  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
Other Information (OTHER INFORMATION)

■ store at 15°-30°C (59°-86°F). Protect from freezing.

■ before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredient (INACTIVE INGREDIENT)

white petrolatum

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Active Ingredient (in each gram)

Bacitracin Zinc, USP            400 units

Neomycin                             3.5mg 

Polymyxin B Sulfate, USP   5,000 units

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-833-285-4151 Monday-Friday 9AM-5PM EST

Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

■ you need to use longer than one week

■ condition persists or gets worse

■ 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 (1-800-222-1222) right away.

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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