1626fa89-cec0-6467-e063-6294a90aa2a4

SPL v1

SPL

SPL Set ID 1626fa89-cec0-6467-e063-6294a90aa2a4

Route

topical

Published

Effective Date 2021-11-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

bacitracin (500 [USP'U]) neomycin (3.5 mg) polymyxin b (10000 [USP'U]) pramoxine (10 mg)

Inactive Ingredients

petrolatum

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph drug active Since 2021-09-05

Purpose

first aid antibiotic External Analgesic

Description

Bacitracin zinc 500 units Neomycin 3.5 mg Polymyxin B sulfate 10,000 units Pramoxine hydrochloride 10 mg

Medication Information

Warnings and Precautions

For external use only

Uses

first aid to help prevent infection in minor

• cuts

• scrapes

• burns

Purpose

first aid antibiotic
External Analgesic

Dosage and Administration

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

Other Information

Store at room temperature

Description

Bacitracin zinc 500 units Neomycin 3.5 mg Polymyxin B sulfate 10,000 units Pramoxine hydrochloride 10 mg

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

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

Section 50566-9

Stop use and ask a doctor if

• the condition persists or gets worse

• a rash or other allergic reaction develops

Section 50569-3

Ask a doctor before use if you have

• deep or puncture wounds

• animal bites

• serious burns

Section 51945-4

Section 53413-1

www.drspharmacyusa.com

Do Not Use

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

Active Ingredients

Bacitracin zinc 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg

Inactive Ingredient

Petrolatum

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Uses

first aid to help prevent infection in minor

• cuts

• scrapes

• burns

Purpose

first aid antibiotic
External Analgesic

Dosage and Administration (34068-7)

DIRECTIONS

Other Information (OTHER INFORMATION)

Store at room temperature

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 50566-9 (50566-9)

Stop use and ask a doctor if

• the condition persists or gets worse

• a rash or other allergic reaction develops

Section 50569-3 (50569-3)

Ask a doctor before use if you have

• deep or puncture wounds

• animal bites

• serious burns

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

www.drspharmacyusa.com

Do Not Use

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

Active Ingredients (Active ingredients)

Bacitracin zinc 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg

Inactive Ingredient

Petrolatum

Advanced Ingredient Data

[{"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1000", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "mg"}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIM", "strengthNumerator": "3.5", "strengthDenominator": "1000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "10000", "strengthDenominator": "1000", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "mg"}, {"name": "PRAMOXINE", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1000", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mg"}, {"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", "34068-7": "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", "34071-1": "For external use only", "50565-1": "KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if • the condition persists or gets worse • a rash or other allergic reaction develops", "50569-3": "Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns", "53413-1": "www.drspharmacyusa.com", "Purpose": "first aid antibiotic External Analgesic", "Do Not Use": "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", "OTHER INFORMATION": "Store at room temperature", "Active ingredients": "Bacitracin zinc 500 units Neomycin 3.5 mg Polymyxin B sulfate 10,000 units Pramoxine hydrochloride 10 mg", "Inactive Ingredient": "Petrolatum"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:58.217306 · Updated: 2026-03-14T23:02:48.423363