2009 Triple Antibiotic

2009 Triple Antibiotic
SPL v3
SPL
SPL Set ID f76d7d18-0fa1-d943-e053-6294a90ac20a
Route
TOPICAL
Published
Effective Date 2023-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Neomycin (5 mg) Bacitracin (400 [iU]) Polymyxin B (5000 [iU])
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-10

Description

Bacitracin Zinc 400 Units

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Bacitracin Zinc 400 Units

Label

Triple Antibiotic Ointment

Use(s)

First aid to help prevent infection in minor cuts, scrapes, and burns

Warnings

For External Use Only

Directions

Clean the affected area. Apply a small amount of the 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

• In the eyes or apply over large areas of the body

• If you are allergic to any of the ingredients

• Longer than 1 week unless directed by a doctor

Questions?

1-888-900-2920 Monday - Friday 8AM - 4PM PST

Active Ingredient

Neomycin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)

Other Information

• Store at room temperature between 15º-30ºC (59º-86ºF)

• Tamper evident. Do not use if packet is torn, cut, or opened.

Inactive Ingredient

White Petrolatum

Ask A Doctor Before Use If

you have deep or puncture wounds, animal bites, or serious burns

Stop Use and Ask A Doctor If

• The 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 Ingredient (in Each Gram)

Bacitracin Zinc 400 Units


Structured Label Content

Label

Triple Antibiotic Ointment

Use(s)

First aid to help prevent infection in minor cuts, scrapes, and burns

Purpose

First Aid Antibiotic

Warnings

For External Use Only

Directions

Clean the affected area. Apply a small amount of the 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)

• In the eyes or apply over large areas of the body

• If you are allergic to any of the ingredients

• Longer than 1 week unless directed by a doctor

Questions?

1-888-900-2920 Monday - Friday 8AM - 4PM PST

Active Ingredient

Neomycin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)

Other Information

• Store at room temperature between 15º-30ºC (59º-86ºF)

• Tamper evident. Do not use if packet is torn, cut, or opened.

Inactive Ingredient

White Petrolatum

Ask A Doctor Before Use If (Ask a doctor before use if)

you have deep or puncture wounds, animal bites, or serious burns

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

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

Bacitracin Zinc 400 Units


Advanced Ingredient Data


Raw Label Data

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