Bacitracin Zinc Ointment, Usp

SPL v2

SPL

SPL Set ID 613cbed4-9790-4e6b-a61b-b7b7a8ee59c9

Route

TOPICAL

Published

Effective Date 2025-03-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (500 [USP'U])

Inactive Ingredients

White Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-03-13

Description

(in each gram) Bacitracin zinc, USP 500 units ............. First aid antibiotic

Purpose

First aid antibiotic

Medication Information

Purpose

First aid antibiotic

Description

(in each gram) Bacitracin zinc, USP 500 units ............. First aid antibiotic

Use(s)

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

Do Not Use

if you are allergic to any of the ingredients
in the eyes
over large areas of the body

Other Information

store at 15⁰C to 30⁰C (59⁰F to 86⁰F)
before using any medication, read all label directions. Keep carton, it contains important information.

Active Ingredient(s)

(in each gram)

Bacitracin zinc, USP 500 units ............. First aid antibiotic

Inactive Ingredients

white petrolatum

Questions Or Comments?

Call 1-833-285-4151

Mfg. Lic. No.: 362

Manufactured by:

Encube Ethicals Pvt. Ltd.

Plot no. C-1, Madkaim

Industrial Estate, Madkaim,

Post: Mardol, Ponda,

Goa - 403 404, India.

Distributed by:

Encube Ethicals, Inc.

200 Meredith Drive,

Suite 202, Durham,

NC 27713, USA

Principal Display Panel

BACITRACIN ZINC OINTMENT, USP

First aid antibiotic

NET WT. 0.5 OZ (14 g)

BACITRACIN ZINC OINTMENT, USP

First aid antibiotic

NET WT. 1 OZ (28 g)

Stop Use and Ask Doctor If

you need to use longer than one week
condition persist or gets worse
rash or other allergic reaction develops

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have

deep or puncture wounds
animal bites
serious burns

Structured Label Content

Use(s) (USE(S))

First Aid to help prevent infection in minor

cuts
scrapes
burns

Purpose (PURPOSE)

First aid antibiotic

Warnings (WARNINGS)

For External Use Only.

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

Do Not Use (DO NOT USE)

if you are allergic to any of the ingredients
in the eyes
over large areas of the body

Other Information (OTHER INFORMATION)

store at 15⁰C to 30⁰C (59⁰F to 86⁰F)
before using any medication, read all label directions. Keep carton, it contains important information.

Active Ingredient(s) (ACTIVE INGREDIENT(S))

(in each gram)

Bacitracin zinc, USP 500 units ............. First aid antibiotic

Inactive Ingredients (INACTIVE INGREDIENTS)

white petrolatum

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-833-285-4151

Mfg. Lic. No.: 362

Manufactured by:

Encube Ethicals Pvt. Ltd.

Plot no. C-1, Madkaim

Industrial Estate, Madkaim,

Post: Mardol, Ponda,

Goa - 403 404, India.

Distributed by:

Encube Ethicals, Inc.

200 Meredith Drive,

Suite 202, Durham,

NC 27713, USA

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BACITRACIN ZINC OINTMENT, USP

First aid antibiotic

NET WT. 0.5 OZ (14 g)

BACITRACIN ZINC OINTMENT, USP

First aid antibiotic

NET WT. 1 OZ (28 g)

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

you need to use longer than one week
condition persist or gets worse
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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

deep or puncture wounds
animal bites
serious burns

Advanced Ingredient Data

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

Raw Label Data

All Sections (JSON)

{"USE(S)": "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", "DO NOT USE": "if you are allergic to any of the ingredients in the eyes over large areas of the body", "OTHER INFORMATION": "store at 15 0 C to 30 0 C (59 0 F to 86 0 F) before using any medication, read all label directions. Keep carton, it contains important information. ", "ACTIVE INGREDIENT(S)": "(in each gram) Bacitracin zinc, USP 500 units ............. First aid antibiotic", "INACTIVE INGREDIENTS": "white petrolatum", "QUESTIONS OR COMMENTS?": "Call 1-833-285-4151 Mfg. Lic. No.: 362 Manufactured by: Encube Ethicals Pvt. Ltd. Plot no. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA", "PRINCIPAL DISPLAY PANEL": "BACITRACIN ZINC OINTMENT, USP First aid antibiotic NET WT. 0.5 OZ (14 g) BACITRACIN ZINC OINTMENT, USP First aid antibiotic NET WT. 1 OZ (28 g)", "STOP USE AND ASK DOCTOR IF": "you need to use longer than one week condition persist or gets worse rash or other allergic reaction develops ", "KEEP OUT OF REACH OF CHILDREN": "If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "ASK A DOCTOR BEFORE USE IF YOU HAVE": "deep or puncture wounds animal bites serious burns "}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:55.413821 · Updated: 2026-03-14T23:09:59.416921