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Live Better

SPL v3

SPL

SPL Set ID 7e7a0b4c-67a9-42f3-aacd-2606fde25090

Route

TOPICAL

Published

Effective Date 2013-03-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (500 [iU]) Neomycin (3.5 mg) Polymyxin B (10000 [iU]) Pramoxine (10 mg)

Inactive Ingredients

Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-03-31

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort 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 ingredients (each gram contains)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	External analgesic

Warnings

For external use only.

Directions

Adults and children 2 years of age and older:
- clean the affected area and dry thoroughly
- 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
Children under 2 years of age: ask a doctor

Do Not Use

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

Questions?

Call 1-866-923-4914

Other Information

To open: unscrew cap, pull tab to remove foil seal
store at 20° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive Ingredient

white petrolatum

Stop Use and Ask A Doctor If

condition persists or gets worse
you need to use longer than 1 week
symptoms persist for more than 1 week, or clear up and occur again within a few days
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 28.4 G Tube Carton

Maximum Strength

Triple Antibiotic Ointment + Pain Relief

■ BACITRACIN ZINC ■ NEOMYCIN SULFATE ■ POLYMYXIN B SULFATE ■ PRAMOXINE HYDROCHLORIDE

First Aid Antibiotic / Pain Relieving Ointment

NET WT 1 OZ (28.4g)

Structured Label Content

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort 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 ingredients (each gram contains)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	External analgesic

Warnings

For external use only.

Directions

Adults and children 2 years of age and older:
- clean the affected area and dry thoroughly
- 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
Children under 2 years of age: ask a doctor

Do Not Use (Do not use)

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

Questions?

Call 1-866-923-4914

Other Information (Other information)

To open: unscrew cap, pull tab to remove foil seal
store at 20° to 25°C (68° to 77°F)
see carton or tube crimp for lot number and expiration date

Inactive Ingredient (Inactive ingredient)

white petrolatum

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

condition persists or gets worse
you need to use longer than 1 week
symptoms persist for more than 1 week, or clear up and occur again within a few days
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 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

Maximum Strength

Triple Antibiotic Ointment + Pain Relief

■ BACITRACIN ZINC ■ NEOMYCIN SULFATE ■ POLYMYXIN B SULFATE ■ PRAMOXINE HYDROCHLORIDE

First Aid Antibiotic / Pain Relieving Ointment

NET WT 1 OZ (28.4g)

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "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": "10000", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "PRAMOXINE", "unii": "068X84E056", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "first aid to help prevent infection and for the temporary relief of pain or discomfort 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 ingredients (each gram contains) Purpose Bacitracin zinc 500 units First aid antibiotic Neomycin sulfate 3.5 mg First aid antibiotic Polymyxin B sulfate 10,000 units First aid antibiotic Pramoxine hydrochloride 10 mg External analgesic", "Warnings": "For external use only.", "Directions": "Adults and children 2 years of age and older: clean the affected area and dry thoroughly 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 Children under 2 years of age: ask a doctor", "Do not use": "in the eyes over large areas of the body if you are allergic to any of the ingredients", "Questions?": "Call 1-866-923-4914", "Other information": "To open: unscrew cap, pull tab to remove foil seal store at 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date", "Inactive ingredient": "white petrolatum", "Stop use and ask a doctor if": "condition persists or gets worse you need to use longer than 1 week symptoms persist for more than 1 week, or clear up and occur again within a few days 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 - 28.4 g Tube Carton": "Maximum Strength Triple Antibiotic Ointment + Pain Relief ■ BACITRACIN ZINC ■ NEOMYCIN SULFATE ■ POLYMYXIN B SULFATE ■ PRAMOXINE HYDROCHLORIDE First Aid Antibiotic / Pain Relieving Ointment NET WT 1 OZ (28.4g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:31.698013 · Updated: 2026-03-14T23:09:21.323328