Bacitracin Ointment

Bacitracin Ointment
SPL v11
SPL
SPL Set ID 5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd9
Route
TOPICAL
Published
Effective Date 2025-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U])
Inactive Ingredients
Light Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2012-04-30 Until 2019-06-12

Description

Bacitracin 500 units

Purpose

First aid antibiotic

How Supplied

28gm tube – 68788-9794-2 Relabeled By: Preferred Pharmaceuticals, Inc


Medication Information

Purpose

First aid antibiotic

How Supplied

28gm tube – 68788-9794-2



Relabeled By: Preferred Pharmaceuticals, Inc

Description

Bacitracin 500 units

Uses

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

Warnings

For external use only

Do not use

• if you are allergic to any of the ingredients

• in the eyes

• over large areas of the body

• longer than 1 week unless directed by a doctor



Ask a doctor before use in case of 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

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

Active Ingredient

Bacitracin 500 units

Other Information

store at room temperature

Inactive Ingredient

light mineral oil, white petrolatum

Keep Out of Reach of Children

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

Package Label.principal Display Panel

Structured Label Content

Uses (USES)

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

Purpose (PURPOSE)

First aid antibiotic

Warnings (WARNINGS)

For external use only

Do not use

• if you are allergic to any of the ingredients

• in the eyes

• over large areas of the body

• longer than 1 week unless directed by a doctor



Ask a doctor before use in case of 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

Directions (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

How Supplied (HOW SUPPLIED)

28gm tube – 68788-9794-2



Relabeled By: Preferred Pharmaceuticals, Inc

Active Ingredient (ACTIVE INGREDIENT)

Bacitracin 500 units

Other Information (OTHER INFORMATION)

store at room temperature

Inactive Ingredient (INACTIVE INGREDIENT)

light mineral oil, white petrolatum

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.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)