Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 43edfb80-4d50-9362-e063-6394a90a2199
Route
TOPICAL
Published
Effective Date 2025-11-19
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 U)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-24

Description

Bacitracin Zinc............400 units Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin) Polymyxin B Sulfate ....5000 units

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc............400 units Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin) Polymyxin B Sulfate ....5000 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) 1 to 3 times daily.

• May be covered with a sterile bandage.

Do Not Use

• in the eyes

• if you are allergic to any of the ingredients

• over large areas of the body or for longer than 1 week unless directed by a doctor

Other Information

Store at 15°–30°C (59°–86°F). Avoid excessive heat and humidity.

Inactive Ingredients

white petrolatum

Principal Display Panel

*Compare to the active ingredient in NEOSPORIN

NDC: 84546-0001-01

Elixir Triple Guard

Ointment

Bacitracin Zinc

Neomycin Sulfate

Polymyxin B Sulfate

First AID ANTIBIOTIC

Elixir

Net Wt. 1 oz, (28.3 gm)

Reorder No: MRP-XXXX

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 right away.

Active Ingredient (in Each Gram)

Bacitracin Zinc............400 units

Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)

Polymyxin B Sulfate ....5000 units

Ask A Doctor Before Use in Case Of

• 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) 1 to 3 times daily.

• May be covered with a sterile bandage.

Do Not Use (Do not use)

• in the eyes

• if you are allergic to any of the ingredients

• over large areas of the body or for longer than 1 week unless directed by a doctor

Other Information (Other information)

Store at 15°–30°C (59°–86°F). Avoid excessive heat and humidity.

Inactive Ingredients (Inactive ingredients)

white petrolatum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

*Compare to the active ingredient in NEOSPORIN

NDC: 84546-0001-01

Elixir Triple Guard

Ointment

Bacitracin Zinc

Neomycin Sulfate

Polymyxin B Sulfate

First AID ANTIBIOTIC

Elixir

Net Wt. 1 oz, (28.3 gm)

Reorder No: MRP-XXXX

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 right away.

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

Bacitracin Zinc............400 units

Neomycin Sulfate 5mg (equivalent to 3.5 mg Neomycin)

Polymyxin B Sulfate ....5000 units

Ask A Doctor Before Use in Case Of (Ask a doctor before use in case of)

• deep or puncture wounds

• animal bites

• serious burns


Advanced Ingredient Data


Raw Label Data

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