SPL v1
SPL
SPL Set ID 024bc706-2da7-4e41-b1bc-60fa1b351463
Route
TOPICAL
Published
Effective Date 2016-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 1)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-10-18

Description

Bacitracin Zinc 500 units


Medication Information

Warnings and Precautions

Warnings:

• for external use only

Indications and Usage

Uses:

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

Dosage and Administration

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

Description

Bacitracin Zinc 500 units

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if:

• 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

Section 50570-1

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

Section 51727-6

Inactive Ingredients:

white petrolatum

Section 51945-4

Section 55105-1

first aid antibiotic

Section 55106-9

Bacitracin Zinc 500 units

Section 60561-8

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)


Structured Label Content

Indications and Usage (34067-9)

Uses:

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings:

• for external use only

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

• 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

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients:

white petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

first aid antibiotic

Section 55106-9 (55106-9)

Bacitracin Zinc 500 units

Section 60561-8 (60561-8)

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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)