SPL v16
SPL
SPL Set ID e115d413-e41c-4e43-8184-493d64dfcd9f
Route
TOPICAL
Published
Effective Date 2024-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1995-01-11

Description

Bacitracin zinc 400 units Neomycin 3.5 mg Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

How Supplied

Product: 50090-0234 NDC: 50090-0234-0 28.4 g in a TUBE


Medication Information

Purpose

First aid antibiotic

How Supplied

Product: 50090-0234

NDC: 50090-0234-0 28.4 g in a TUBE

Description

Bacitracin zinc 400 units Neomycin 3.5 mg Polymyxin B sulfate 5,000 units

Uses

first aid to help prevent infection in minor

• cuts

• scrapes

• burns

Warnings

For external use only

Do not use

• if you are allergic to any of the ingredients

• in the eyes

• over large areas of the body

• longer than 1 week unless directed by a doctor



Ask a doctor before use if you have

• deep or puncture wounds

• animal bites

• serious burns



Stop use and ask a doctor if  

• the condition persists or gets worse

• a rash or other allergic reaction develops

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

Other Information

store at room temperature

Inactive Ingredient

light mineral oil, white petrolatum

Triple Antibiotic Ointment
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 3.5 mg

Polymyxin B sulfate 5,000 units


Structured Label Content

Uses (USES)

first aid to help prevent infection in minor

• cuts

• scrapes

• burns

Purpose (PURPOSE)

First aid antibiotic

Warnings (WARNINGS)

For external use only

Do not use

• if you are allergic to any of the ingredients

• in the eyes

• over large areas of the body

• longer than 1 week unless directed by a doctor



Ask a doctor before use if you have

• deep or puncture wounds

• animal bites

• serious burns



Stop use and ask a doctor if  

• the condition persists or gets worse

• a rash or other allergic reaction develops

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

How Supplied (HOW SUPPLIED)

Product: 50090-0234

NDC: 50090-0234-0 28.4 g in a TUBE

Other Information (OTHER INFORMATION)

store at room temperature

Inactive Ingredient (INACTIVE INGREDIENT)

light mineral oil, white petrolatum

Triple Antibiotic Ointment (TRIPLE ANTIBIOTIC OINTMENT)
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 3.5 mg

Polymyxin B sulfate 5,000 units


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)