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

Triple Antibiotic Ointment (bacitracin Zinc - Neomycin Sulfate - Polymyxin b Sulfate)
SPL v2
SPL
SPL Set ID 2e985ad0-aa50-4c6b-b0af-1d61489a9fda
Route
TOPICAL
Published
Effective Date 2025-03-28
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 2025-03-06

Description

Bacitracin Zinc USP, 400 units Neomycin 3.5 mg                                       Polymyxin B Sulfate USP, 5,000 units

Purpose

First aid antibiotic


Medication Information

Purpose

First aid antibiotic

Description

Bacitracin Zinc USP, 400 units Neomycin 3.5 mg                                       Polymyxin B Sulfate USP, 5,000 units

Uses

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°C to 30°C (59°F to 86°F). Protect from freezing.

■ 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

Triple Antibiotic Ointment

(Bacitracin zinc - Neomycin sulfate - Polymyxin B sulfate Ointment)

First aid antibiotic

NDC 21922-093-04

Net wt. 0.5 oz (14g)



Triple Antibiotic Ointment

(Bacitracin zinc - Neomycin sulfate - Polymyxin B sulfate Ointment)

First aid antibiotic

NDC 21922-093-05

Net wt. 1 oz (28g)



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.

Active Ingredients (in Each Gram)

Bacitracin Zinc USP, 400 units

Neomycin 3.5 mg                                      

Polymyxin B Sulfate USP, 5,000 units

Ask A Doctor Before Use If You Have

■ deep or puncture wounds

■ animal bites

■ serious burns


Structured Label Content

Uses

First aid to help prevent infection in minor

  • cuts
  • scrapes
  • 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)
  • 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°C to 30°C (59°F to 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

Questions Or Comments? (Questions or comments?)

Call 1-833-285-4151

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Triple Antibiotic Ointment

(Bacitracin zinc - Neomycin sulfate - Polymyxin B sulfate Ointment)

First aid antibiotic

NDC 21922-093-04

Net wt. 0.5 oz (14g)



Triple Antibiotic Ointment

(Bacitracin zinc - Neomycin sulfate - Polymyxin B sulfate Ointment)

First aid antibiotic

NDC 21922-093-05

Net wt. 1 oz (28g)



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.

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

Bacitracin Zinc USP, 400 units

Neomycin 3.5 mg                                      

Polymyxin B Sulfate USP, 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

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