Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 50085398-7ffd-485f-9d60-f7252fa5c9b9

Route

TOPICAL

Published

Effective Date 2012-08-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Marketing Status

OTC MONOGRAPH FINAL Active Since 2012-08-01

Description

Bacitracin Zinc 500 units Neomycin 3.5mg Polymyxin B Sulfate 10,000 units Pramoxine HCl 10mg

Purpose

First aid antibiotic First aid antibiotic First aid antibiotic External analgesic

Medication Information

Purpose

First aid antibiotic

External analgesic

Description

Bacitracin Zinc 500 units Neomycin 3.5mg Polymyxin B Sulfate 10,000 units Pramoxine HCl 10mg

Uses

First aid to help prevent infection and provide temporary relief of pain or discomfort in minor

cuts
scrapes
burns

Warnings

For external use only

Directions

adults and children 2 years of age and older:
- 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
children under 2 years of age: consult a physician

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 20°-25°C (68°-77°F)

Inactive Ingredient

white petrolatum

Principal Display Panel

Triple Antibiotic Ointment Plus Pain Relief

Stop Use and Ask A Doctor If

you need to use longer than 1 week
condition persists or gets worse
condition persists for more than 1 week, or clear up and occur again within a few days
a rash or other allergic reaction develops

Keep Out of Reach of Children.

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

Active Ingredients (in Each Gram)

Bacitracin Zinc 500 units

Neomycin 3.5mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

Ask A Doctor Before Use If You Have

deep or puncture wounds
animal bites
serious burns

Structured Label Content

Uses

First aid to help prevent infection and provide temporary relief of pain or discomfort in minor

cuts
scrapes
burns

Purpose

First aid antibiotic

External analgesic

Warnings

For external use only

Directions

adults and children 2 years of age and older:
- 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
children under 2 years of age: consult a physician

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 20°-25°C (68°-77°F)

Inactive Ingredient (Inactive ingredient)

white petrolatum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Triple Antibiotic Ointment Plus Pain Relief

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

you need to use longer than 1 week
condition persists or gets worse
condition persists for more than 1 week, or clear up and occur again within a few days
a 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 right away.

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Bacitracin Zinc 500 units

Neomycin 3.5mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

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": "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": "[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 and provide temporary relief of pain or discomfort in minor cuts scrapes burns", "Purpose": "First aid antibiotic First aid antibiotic First aid antibiotic External analgesic", "Warnings": "For external use only", "Directions": "adults and children 2 years of age and older: 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 children under 2 years of age: consult a physician", "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 20°-25°C (68°-77°F)", "Inactive ingredient": "white petrolatum", "PRINCIPAL DISPLAY PANEL": "Triple Antibiotic Ointment Plus Pain Relief", "Stop use and ask a doctor if": "you need to use longer than 1 week condition persists or gets worse condition persists for more than 1 week, or clear up and occur again within a few days a rash or other allergic reaction develops", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Active ingredients (in each gram)": "Bacitracin Zinc 500 units Neomycin 3.5mg Polymyxin B Sulfate 10,000 units Pramoxine HCl 10mg", "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: 2026-02-15T11:55:30.476086 · Updated: 2026-03-14T22:53:15.110984