Triple Antibiotic

SPL v3

SPL

SPL Set ID a44db5d1-7a74-44aa-9aa7-6247e771aaf2

Route

TOPICAL

Published

Effective Date 2019-01-17

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

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 (in each gram)	Purpose
Bacitracin zinc USP 500 units	First aid antibiotic
Neomycin sulfate USP 3.5 mg	First aid antibiotic
Polymyxin B sulfate USP 10,000 units	First aid antibiotic
Pramoxine HCl USP 10 mg	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: ask a doctor

Do Not Use

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

Questions?

Call 1-866-923-4914

Other Information

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

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

TRIPLE ANTIBIOTIC

OINTMENT

+ PAIN RELIEF

MAXIMUM STRENGTH

Bacitracin Zinc USP • Neomycin Sulfate USP • Polymyxin B

Sulfate USP • Pramoxine Hydrochloride USP

FIRST AID ANTIBIOTIC / PAIN RELIEVING OINTMENT

Helps Prevent Infection in Minor Cuts, Scrapes,

and Burns Plus Maximum Strength Pain Relief.

NET WT 0.5 oz (14.2 g)

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 (in each gram)	Purpose
Bacitracin zinc USP 500 units	First aid antibiotic
Neomycin sulfate USP 3.5 mg	First aid antibiotic
Polymyxin B sulfate USP 10,000 units	First aid antibiotic
Pramoxine HCl USP 10 mg	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: ask a doctor

Do Not Use (Do not use)

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

Questions?

Call 1-866-923-4914

Other Information (Other information)

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)

you need to use longer than 1 week
condition persists or gets worse
symptoms persist for more than 1 week, or clear up and occur again within a few days
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 14.2 G Tube Carton (PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton)

TRIPLE ANTIBIOTIC

OINTMENT

+ PAIN RELIEF

MAXIMUM STRENGTH

Bacitracin Zinc USP • Neomycin Sulfate USP • Polymyxin B

Sulfate USP • Pramoxine Hydrochloride USP

FIRST AID ANTIBIOTIC / PAIN RELIEVING OINTMENT

Helps Prevent Infection in Minor Cuts, Scrapes,

and Burns Plus Maximum Strength Pain Relief.

NET WT 0.5 oz (14.2 g)

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIB", "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"}]

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 (in each gram) Purpose Bacitracin zinc USP 500 units First aid antibiotic Neomycin sulfate USP 3.5 mg First aid antibiotic Polymyxin B sulfate USP 10,000 units First aid antibiotic Pramoxine HCl USP 10 mg 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: ask a doctor", "Do not use": "if you are allergic to any of the ingredients in the eyes over large areas of the body", "Questions?": "Call 1-866-923-4914", "Other information": "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": "you need to use longer than 1 week condition persists or gets worse symptoms persist for more than 1 week, or clear up and occur again within a few days 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 - 14.2 g Tube Carton": "TRIPLE ANTIBIOTIC OINTMENT + PAIN RELIEF MAXIMUM STRENGTH Bacitracin Zinc USP • Neomycin Sulfate USP • Polymyxin B Sulfate USP • Pramoxine Hydrochloride USP FIRST AID ANTIBIOTIC / PAIN RELIEVING OINTMENT Helps Prevent Infection in Minor Cuts, Scrapes, and Burns Plus Maximum Strength Pain Relief. NET WT 0.5 oz (14.2 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:31.721617 · Updated: 2026-03-14T23:09:21.323328