medichoice triple antibiotic

medichoice triple antibiotic
SPL v6
SPL
SPL Set ID 8369f399-6f64-4441-be72-1f16c7306c0a
Route
topical
Published
Effective Date 2018-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bacitracin (400 [iU]) neomycin (5 mg) polymyxin b (5000 [iU])
Inactive Ingredients
petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-03-27

Purpose

first aid antibiotic

Description

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


Medication Information

Warnings

• for external use only

Uses

First aid to help prevent infection in: • minor cuts • scrapes • burns

Purpose

first aid antibiotic

Description

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

Drug Facts

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:

• in the eyes or over large areas of the body.  In case of deep puncture wounds, animal bites, or serious burns, consult a doctor.  • Do not use if you are allergic to any of the ingredients. • Do not use longer than 1 week unless directed by a doctor

Product Labels

Active Ingredient

Bacitracin 400 units

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg. Neomycin)

Polymyxin B Sulfate 5000 units

Other Information:

• Tamper Evident. Do not use if packet is torn, cut or opened. • Avoid excessive heat and humidity • Store at a controlled room temperature 15˚ to 30˚C (59˚ to 86˚F)



Inactive Ingredients:

white petrolatum.

Stop Use and Ask A Doctor:

• if the condition persists or gets worse, or if 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.


Structured Label Content

Warnings

• for external use only

Uses

First aid to help prevent infection in: • minor cuts • scrapes • burns

Purpose

first aid antibiotic

Drug Facts

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:)

• in the eyes or over large areas of the body.  In case of deep puncture wounds, animal bites, or serious burns, consult a doctor.  • Do not use if you are allergic to any of the ingredients. • Do not use longer than 1 week unless directed by a doctor

Product Labels

Active Ingredient

Bacitracin 400 units

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg. Neomycin)

Polymyxin B Sulfate 5000 units

Other Information:

• Tamper Evident. Do not use if packet is torn, cut or opened. • Avoid excessive heat and humidity • Store at a controlled room temperature 15˚ to 30˚C (59˚ to 86˚F)



Inactive Ingredients:

white petrolatum.

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

• if the condition persists or gets worse, or if 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.


Advanced Ingredient Data


Raw Label Data

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