Double Antibiotic Ointment (bacitracin Zinc And Polymyxin B Sulfate Ointment, Usp)

Double Antibiotic Ointment (bacitracin Zinc And Polymyxin B Sulfate Ointment, Usp)
SPL v2
SPL
SPL Set ID 8f00b059-6729-4fae-8e8c-e14fe8838c59
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-06

Description

Bacitracin Zinc, USP            500 units Polymyxin B Sulfate, USP   10,000 units

Purpose

First aid antibiotic


Medication Information

Purpose

First aid antibiotic

Description

Bacitracin Zinc, USP            500 units Polymyxin B Sulfate, USP   10,000 units

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Warnings

For external use only

Allergy alert  ■ do not use if allergic to any of the ingredients

Do not use ■ in the eyes ■ over large areas of the body

Directions

■ clean 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 15°C to 25°C (59°F to 77°F).

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

Inactive Ingredient

white petrolatum

Questions Or Comments?

Call 1-833-285-4151

Principal Display Panel

Double Antibiotic Ointment

First Aid Antibiotic

Net wt. 1 oz (28g)

Stop Use and Ask A Doctor If

■ 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 (1-800-222-1222) right away.

Active Ingredients (in Each Gram)

Bacitracin Zinc, USP            500 units

Polymyxin B Sulfate, USP   10,000 units

Ask A Doctor Before Use If You Have

■ deep or puncture wounds

■ animal bites

■ serious burns

When using this product

■ do not use longer than 1 week unless directed by a doctor


Structured Label Content

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

Warnings

For external use only

Allergy alert  ■ do not use if allergic to any of the ingredients

Do not use ■ in the eyes ■ over large areas of the body

Directions

■ clean 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 15°C to 25°C (59°F to 77°F).

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

Inactive Ingredient (Inactive ingredient)

white petrolatum

Questions Or Comments? (Questions or comments?)

Call 1-833-285-4151

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Double Antibiotic Ointment

First Aid Antibiotic

Net wt. 1 oz (28g)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

■ 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 (1-800-222-1222) right away.

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

Bacitracin Zinc, USP            500 units

Polymyxin B Sulfate, USP   10,000 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

When using this product

■ do not use longer than 1 week unless directed by a doctor


Advanced Ingredient Data


Raw Label Data

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