Double Antibiotic Ointment

SPL v4

SPL

SPL Set ID f64b3564-ea3c-4316-8f00-f92c08dcad35

Route

TOPICAL

Published

Effective Date 2026-02-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (500 [USP'U]) Polymyxin B (10000 [USP'U])

Inactive Ingredients

Petrolatum

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-09-15

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

First aid to help prevent infection in

minor cuts
scrapes
burns

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 55105-1

Active ingredient (in each gram)	Purpose
Bacitracin Zinc 500 units	First Aid Double Antibiotic
Polymyxin B 10,000 units	First Aid Double 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

in the eyes
over large areas of the body
longer than 1 week unless directed by a doctor

Allergy Alert

Do not use if allergic to any of the ingredients

Other Information

Before using any medication, read all directions
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]

Inactive Ingredients

White Petrolatum

Questions Or Comments?

Call Customer Service at 1-800-442-7882

Stop Use and Ask A Doctor If

the condition persists or gets worse
a rash or other allergic reaction develops

Ask A Doctor Before Use If You Have

deep or puncture wounds
animal bites
serious burns

Principal Display Panel 28.35 Gm Tube Box

NDC 58980-012-10

STRATUSCARE

Double Antibiotic Ointment

(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

First Aid Antibiotic

Net Wt. 1.0 OZ (28.35 gm)

Distributed by:

STRATUS

PHARMACEUTICALS INC

Structured Label Content

Uses

First aid to help prevent infection in

minor cuts
scrapes
burns

Section 42229-5 (42229-5)

Drug Facts

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 55105-1 (55105-1)

Active ingredient (in each gram)	Purpose
Bacitracin Zinc 500 units	First Aid Double Antibiotic
Polymyxin B 10,000 units	First Aid Double 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 (Do not use)

in the eyes
over large areas of the body
longer than 1 week unless directed by a doctor

Allergy Alert (Allergy alert)

Do not use if allergic to any of the ingredients

Other Information (Other information)

Before using any medication, read all directions
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]

Inactive Ingredients (Inactive ingredients)

White Petrolatum

Questions Or Comments? (Questions or comments?)

Call Customer Service at 1-800-442-7882

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

the condition persists or gets worse
a rash or other allergic reaction develops

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

deep or puncture wounds
animal bites
serious burns

Principal Display Panel 28.35 Gm Tube Box (PRINCIPAL DISPLAY PANEL - 28.35 gm Tube Box)

NDC 58980-012-10

STRATUSCARE

Double Antibiotic Ointment

(Bacitracin Zinc and Polymyxin B Sulfate Ointment USP)

First Aid Antibiotic

Net Wt. 1.0 OZ (28.35 gm)

Distributed by:

STRATUS

PHARMACEUTICALS INC

Advanced Ingredient Data

[{"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "10000", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "First aid to help prevent infection in minor cuts scrapes burns", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away", "55105-1": "Active ingredient (in each gram) Purpose Bacitracin Zinc 500 units First Aid Double Antibiotic Polymyxin B 10,000 units First Aid Double 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": "in the eyes over large areas of the body longer than 1 week unless directed by a doctor", "Allergy alert": "Do not use if allergic to any of the ingredients", "Other information": "Before using any medication, read all directions Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]", "Inactive ingredients": "White Petrolatum", "Questions or comments?": "Call Customer Service at 1-800-442-7882", "Stop use and ask a doctor if": "the condition persists or gets worse a rash or other allergic reaction develops", "Ask a doctor before use if you have": "deep or puncture wounds animal bites serious burns", "PRINCIPAL DISPLAY PANEL - 28.35 gm Tube Box": "NDC 58980-012-10 STRATUSCARE Double Antibiotic Ointment (Bacitracin Zinc and Polymyxin B Sulfate Ointment USP) First Aid Antibiotic Net Wt. 1.0 OZ (28.35 gm) Distributed by: STRATUS PHARMACEUTICALS INC"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:36.538384 · Updated: 2026-03-14T23:12:55.175782