Triple Antibiotic

SPL v1

SPL

SPL Set ID 2c8b5a71-51cf-4274-aacc-411dfd1f05e5

Route

TOPICAL

Published

Effective Date 2010-09-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2010-09-23

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 50566-9

Stop use and ask a doctor if

condition persists or gets worse
condition persists for more than 7 days
condition clears up and occurs again within a few days
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 50570-1

Do not use

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

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 HCI 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: consult a doctor

Questions?

Call 1-877-745-6888

Other Information

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

Inactive Ingredient

white petrolatum

Principal Display Panel 28.4 G Tube Carton

Triple Antibiotic

Ointment + Pain Relief

Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic / Pain Relieving Ointment

Maximum Strength

NET WT 1 oz (28.4 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 50566-9 (50566-9)

Stop use and ask a doctor if

condition persists or gets worse
condition persists for more than 7 days
condition clears up and occurs again within a few days
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 50570-1 (50570-1)

Do not use

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

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 HCI 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: consult a doctor

Questions?

Call 1-877-745-6888

Other Information (Other information)

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

Inactive Ingredient (Inactive ingredient)

white petrolatum

Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

Triple Antibiotic

Ointment + Pain Relief

Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl

First Aid Antibiotic / Pain Relieving Ointment

Maximum Strength

NET WT 1 oz (28.4 g)

Advanced Ingredient Data

[{"name": "Bacitracin Zinc", "unii": "89Y4M234ES", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "Neomycin", "unii": "I16QD7X297", "classCode": "ACTIB", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Polymyxin B", "unii": "J2VZ07J96K", "classCode": "ACTIB", "strengthNumerator": "10000", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "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 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.", "50566-9": "Stop use and ask a doctor if condition persists or gets worse condition persists for more than 7 days condition clears up and occurs again within a few days 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", "50570-1": "Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients", "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 HCI 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: consult a doctor", "Questions?": "Call 1-877-745-6888", "Other information": "To open: unscrew cap, pull tab to remove foil seal. store at 20°-25°C (68°-77°F) See carton or tube crimp for lot number and expiration date.", "Inactive ingredient": "white petrolatum", "PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton": "Triple Antibiotic Ointment + Pain Relief Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine HCl First Aid Antibiotic / Pain Relieving Ointment Maximum Strength NET WT 1 oz (28.4 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:08.700731 · Updated: 2026-03-14T22:52:29.225907