Triple Antibiotic Ointment

Triple Antibiotic Ointment
SPL v3
SPL
SPL Set ID 39893365-c94f-bc83-67f6-0005d5f2aa24
Route
TOPICAL
Published
Effective Date 2023-12-20
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


Medication Information

Purpose

First aid antibiotic

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

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

Package Label.principal Display Panel

Cosette Pharmaceuticals, Inc.



Triple Antibiotic Ointment


FIRST AID ANTIBIOTIC OINTMENT

Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate

Net Wt. 1 oz (28.4 g)


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

Other Information (OTHER INFORMATION)

store at room temperature

Inactive Ingredient (INACTIVE INGREDIENT)

light mineral oil, white petrolatum

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Cosette Pharmaceuticals, Inc.



Triple Antibiotic Ointment


FIRST AID ANTIBIOTIC OINTMENT

Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate

Net Wt. 1 oz (28.4 g)


Advanced Ingredient Data


Raw Label Data

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