5fb447d6-dbbf-6745-e053-2a91aa0ae0bf

SPL v3

SPL

SPL Set ID 5fb447d6-dbbf-6745-e053-2a91aa0ae0bf

Route

topical

Published

Effective Date 2018-02-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

bacitracin (400 [USP'U]) neomycin (3.5 mg) polymyxin b (5000 [USP'U]) pramoxine (10 mg)

Inactive Ingredients

petrolatum

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph final active Since 2017-12-06

Purpose

first aid antibiotic External Analgesic

Description

Bacitracin zinc 400 units Neomycin 3.5 mg Polymyxin B sulfate 5,000 units Pramoxine hydrochloride 10 mg

Medication Information

Warnings

For external use only

Uses

first aid to help prevent infection in minor

• cuts

• scrapes

• burns

Purpose

first aid antibiotic
External Analgesic

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 400 units Neomycin 3.5 mg Polymyxin B sulfate 5,000 units Pramoxine hydrochloride 10 mg

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

Net Weight 0.33 oz (9.4g0

NDC#70648-121-01

Questions

www.ohiolabpharma.us

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 400 units

Neomycin 3.5 mg

Polymyxin B sulfate 5,000 units

Pramoxine hydrochloride 10 mg

Inactive Ingredient

Petrolatum

Keep Out of Reach of Children

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

Structured Label Content

Warnings

For external use only

Uses (USES)

first aid to help prevent infection in minor

• cuts

• scrapes

• burns

Purpose

first aid antibiotic
External Analgesic

Directions

Other Information (Other information)

Store at room temperature

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)

Net Weight 0.33 oz (9.4g0

NDC#70648-121-01

Questions

www.ohiolabpharma.us

Do Not Use (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 400 units

Neomycin 3.5 mg

Polymyxin B sulfate 5,000 units

Pramoxine hydrochloride 10 mg

Inactive Ingredient (Inactive ingredient)

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.

Advanced Ingredient Data

[{"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIM", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "5000", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "PRAMOXINE", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "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", "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", "51945-4": "Net Weight 0.33 oz (9.4g0 NDC#70648-121-01", "Purpose": "first aid antibiotic External Analgesic", "Warnings": "For external use only", "Questions": "www.ohiolabpharma.us", "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 • longer than 1 week unless directed by a doctor", "Other information": "Store at room temperature", "Active ingredients": "Bacitracin zinc 400 units Neomycin 3.5 mg Polymyxin B sulfate 5,000 units Pramoxine hydrochloride 10 mg", "Inactive ingredient": "Petrolatum", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:41.019231 · Updated: 2026-03-14T22:55:19.604592