Medichoice Bacitracin

Medichoice Bacitracin
SPL v9
SPL
SPL Set ID 78079b94-c6fc-4529-aaad-8186924ecba5
Route
TOPICAL
Published
Effective Date 2015-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [iU])
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-03-26 Until 2017-05-31

Description

Bacitracin 500 units

Purpose

First aid antibiotic


Medication Information

Purpose

First aid antibiotic

Description

Bacitracin 500 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) on the area 1 to 3 times daily • may be covered with a sterile bandage



Drug Facts

Do Not Use:

• in the eyes • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock • over large areas of the body • longer than 1 week unless directed by a doctor





Product Labels

Other Information:

• Tamper Evident. Do not use if package 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:

• before use in case of deep puncture wounds, animal bites or serious burns • if the condition persists or gets worse • 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.

Active Ingredient (in Each Gram)

Bacitracin 500 units


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) on the area 1 to 3 times daily • may be covered with a sterile bandage



Drug Facts

Do Not Use: (Do not use:)

• in the eyes • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock • over large areas of the body • longer than 1 week unless directed by a doctor





Product Labels

Other Information:

• Tamper Evident. Do not use if package 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:)

• before use in case of deep puncture wounds, animal bites or serious burns • if the condition persists or gets worse • 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.

Active Ingredient (in Each Gram) (Active Ingredient (In Each Gram))

Bacitracin 500 units


Advanced Ingredient Data


Raw Label Data

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