SPL v2
SPL
SPL Set ID dfc148c1-d1bb-4230-b8cf-9457b99d4e8a
Route
TOPICAL
Published
Effective Date 2017-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (0.51 g)
Inactive Ingredients
Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-13

Description

Active ingredients (in each gram) Bacitracin zinc, USP 500 units


Medication Information

Warnings and Precautions

Warnings For external use only

Allergy alert

•do not use if allergic to any of the ingredients

Do not use

•in or near eyes

•on large areas of the body

Ask a doctor before use if you have

•deep or puncture wounds

•animal bites •serious burns

When using this product

•do not use longer than 1 week

Stop use and ask a doctor if

•condtions last or gets worse

•symptoms last for more than 7 days or clear up and

come back within a few days

•if rash or other allergic reaction occurs

Indications and Usage

Uses

first aid to help prevent infection in

•minor cuts  •scrapes  •burns

Dosage and Administration

Directions

•adults and children 2 years of age and older:

•clean affected area

•apply a small amount (equal to surface area of tip of

finger) on area 1 to 3 times dailt

•may be covered by a sterile bandage

•children under 2 years of age:

•ask a doctor

Description

Active ingredients (in each gram) Bacitracin zinc, USP 500 units

Section 50565-1

If swallowed, get medical Keep out of reach of children.

help or contact a Poison Control Center right away.

Section 51727-6

mineral oil, white petrolatum Inactive ingredients

Section 51945-4

Section 53413-1

1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

Section 55105-1

Purpose

First aid antibiotic

Section 55106-9

Active ingredients (in each gram)

Bacitracin zinc, USP 500 units

Section 60561-8

Other Information

•Store at room temperature 54° - 77° (15° - 25° C)

•Before using any medication, read all label direcitons.

Keep carton. It contains important information


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

•adults and children 2 years of age and older:

•clean affected area

•apply a small amount (equal to surface area of tip of

finger) on area 1 to 3 times dailt

•may be covered by a sterile bandage

•children under 2 years of age:

•ask a doctor

Warnings and Precautions (34071-1)

Warnings For external use only

Allergy alert

•do not use if allergic to any of the ingredients

Do not use

•in or near eyes

•on large areas of the body

Ask a doctor before use if you have

•deep or puncture wounds

•animal bites •serious burns

When using this product

•do not use longer than 1 week

Stop use and ask a doctor if

•condtions last or gets worse

•symptoms last for more than 7 days or clear up and

come back within a few days

•if rash or other allergic reaction occurs

Section 50565-1 (50565-1)

If swallowed, get medical Keep out of reach of children.

help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

mineral oil, white petrolatum Inactive ingredients

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

Section 55105-1 (55105-1)

Purpose

First aid antibiotic

Section 55106-9 (55106-9)

Active ingredients (in each gram)

Bacitracin zinc, USP 500 units

Section 60561-8 (60561-8)

Other Information

•Store at room temperature 54° - 77° (15° - 25° C)

•Before using any medication, read all label direcitons.

Keep carton. It contains important information


Advanced Ingredient Data


Raw Label Data

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