Triple Antibiotic Plus Pain Relief

SPL v5

SPL

SPL Set ID 4545c043-8e8e-4288-b4d8-e6ec9d72f979

Route

TOPICAL

Published

Effective Date 2019-03-15

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

White Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-03-31

Description

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 HCl 10 mg External analgesic

Medication Information

Description

Uses

first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:

cuts
scrapes
burns

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 HCl 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

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
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 Label

First Aid Antibiotic

Pain Relieving Ointment

Maximum Strength

Triple Antibiotic

Ointment + Pain

Relief

Bacitracin Zinc ∙ Neomycin Sulfate

Polymyxin B Sulfate ∙ Pramoxine Hydrochloride

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 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 HCl 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)

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
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 Label (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Label)

First Aid Antibiotic

Pain Relieving Ointment

Maximum Strength

Triple Antibiotic

Ointment + Pain

Relief

Bacitracin Zinc ∙ Neomycin Sulfate

Polymyxin B Sulfate ∙ Pramoxine Hydrochloride

NET WT 1 oz (28.4 g)

Advanced Ingredient Data

[{"name": "WHITE PETROLATUM", "unii": "B6E5W8RQJ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIB", "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", "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 HCl 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": "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 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 Label": "First Aid Antibiotic Pain Relieving Ointment Maximum Strength Triple Antibiotic Ointment + Pain Relief Bacitracin Zinc ∙ Neomycin Sulfate Polymyxin B Sulfate ∙ Pramoxine Hydrochloride NET WT 1 oz (28.4 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:25.612139 · Updated: 2026-03-14T23:09:12.253423