Bacitracin Zinc Ointment

SPL v3

SPL

SPL Set ID b6599a77-37c0-deec-e053-2995a90abd0e

Route

TOPICAL

Published

Effective Date 2020-12-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (500 [USP'U])

Inactive Ingredients

Paraffin Mineral Oil White Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2020-12-09

Description

Bacitracin Zinc 500 units

Purpose

First aid antibiotic

Medication Information

Purpose

First aid antibiotic

Description

Bacitracin Zinc 500 units

Uses

First aid to help prevent infection in

scrapes
minor cuts
burns

Warnings

EXTERNAL USE ONLY

Directions

clean 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
if you are allergic to any of the ingredients
over large areas of the body
longer than 1 week unless directed by a doctor

Active Ingredient

Bacitracin Zinc 500 units

Other Information

Store at room temperature 15° to 25°C (59° to 77°F).
Before using any medication, read all label directions.

Keep carton, it contains important information.

Lot No./Exp. Date: see crimp of tube.

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel

Bacitracin Zinc Ointment

NET WT 0.5 OZ (14g)

Stop Use and Ask A Doctor If

you need to use longer than 1 week
condition persists or gets worse
symptoms persists for more than 1 week or clear up and occur again within a few days
a rash or other allergic reaction develops

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center immediately.

Before Using, Consult A Doctor If You Have

deep or puncture wounds
animal bites
serious burns

Structured Label Content

Uses (USES)

First aid to help prevent infection in

scrapes
minor cuts
burns

Purpose

First aid antibiotic

Warnings (WARNINGS)

EXTERNAL USE ONLY

Directions (DIRECTIONS)

clean 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
if you are allergic to any of the ingredients
over large areas of the body
longer than 1 week unless directed by a doctor

Active Ingredient

Bacitracin Zinc 500 units

Other Information (Other information)

Store at room temperature 15° to 25°C (59° to 77°F).
Before using any medication, read all label directions.

Keep carton, it contains important information.

Lot No./Exp. Date: see crimp of tube.

Inactive Ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Bacitracin Zinc Ointment

NET WT 0.5 OZ (14g)

Stop Use and Ask A Doctor If (STOP USE and ask a doctor if)

you need to use longer than 1 week
condition persists or gets worse
symptoms persists for more than 1 week or clear up and occur again within a few days
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 immediately.

Before Using, Consult A Doctor If You Have (Before using, consult a doctor if you have)

deep or puncture wounds
animal bites
serious burns

Advanced Ingredient Data

[{"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"USES": "First aid to help prevent infection in scrapes minor cuts burns", "Purpose": "First aid antibiotic", "WARNINGS": "EXTERNAL USE ONLY", "DIRECTIONS": "clean 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 if you are allergic to any of the ingredients over large areas of the body longer than 1 week unless directed by a doctor", "Active Ingredient": "Bacitracin Zinc 500 units", "Other information": "Store at room temperature 15° to 25°C (59° to 77°F). Before using any medication, read all label directions. Keep carton, it contains important information. Lot No./Exp. Date: see crimp of tube.", "Inactive Ingredients": "Hard Paraffin, Liquid Paraffin, White Soft Paraffin", "PRINCIPAL DISPLAY PANEL": "Bacitracin Zinc Ointment NET WT 0.5 OZ (14g)", "STOP USE and ask a doctor if": "you need to use longer than 1 week condition persists or gets worse symptoms persists for more than 1 week or clear up and occur again within a few days a rash or other allergic reaction develops", "KEEP OUT OF REACH OF CHILDREN": "If swallowed get medical help or contact a Poison Control Center immediately.", "Before using, consult a doctor if you have": "deep or puncture wounds animal bites serious burns"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:05.440187 · Updated: 2026-03-14T23:00:25.149305