Theracare Triple Antibiotic Ointment

SPL v2

SPL

SPL Set ID 0c3fc798-9a97-5316-e063-6394a90a6830

Route

TOPICAL

Published

Effective Date 2023-12-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Polymyxin B (5000 [iU]) Bacitracin (400 [iU]) Neomycin (3.5 mg)

Inactive Ingredients

Mineral Oil Water Petrolatum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-12-01

Description

Bacitracin zinc Neomycin sulfate Polymyxin B Sulfate

Medication Information

Description

Bacitracin zinc Neomycin sulfate Polymyxin B Sulfate

Use

first aid to help prevent infection 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.(1-800-222-1222)

Section 55105-1

Active ingredients (in each gram)	Purpose
Bacitracin 400 units	First aid antibiotic
Neomycin 3.5 mg	First aid antibiotic
Polymyxin B 5,000 units	First aid antibiotic

Warnings

For external use only.

Directions

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

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° to 25°C (68° to 77° F)
do not use if tube seal under cap is broken

Active Ingredients

Bacitracin zinc
Neomycin sulfate
Polymyxin B Sulfate

Inactive Ingredients

mineral oil, petrolatum, water

When Using This Product

use only as directed

Stop Use and Ask A Doctor If

you need to use longer than 1 week
condition persists or gets worse
rash or other allergic reaction develops

Ask A Doctor Before Use If You Have

deep or puncture wounds
animal bites
serious burns

Theracare Triple Antibiotic Ointment

Structured Label Content

Use

first aid to help prevent infection 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.(1-800-222-1222)

Section 55105-1 (55105-1)

Active ingredients (in each gram)	Purpose
Bacitracin 400 units	First aid antibiotic
Neomycin 3.5 mg	First aid antibiotic
Polymyxin B 5,000 units	First aid antibiotic

Warnings

For external use only.

Directions

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

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° to 25°C (68° to 77° F)
do not use if tube seal under cap is broken

Active Ingredients

Bacitracin zinc
Neomycin sulfate
Polymyxin B Sulfate

Inactive Ingredients (Inactive ingredients)

mineral oil, petrolatum, water

When Using This Product (When Using this product)

use only as directed

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
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

Theracare Triple Antibiotic Ointment (TheraCare Triple Antibiotic Ointment)

Advanced Ingredient Data

[{"name": "POLYMYXIN B", "unii": "J2VZ07J96K", "classCode": "ACTIM", "strengthNumerator": "5000", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "[iU]", "strengthDenominatorUnit": "g"}, {"name": "NEOMYCIN", "unii": "I16QD7X297", "classCode": "ACTIM", "strengthNumerator": "3.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Use": "first aid to help prevent infection 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.(1-800-222-1222)", "55105-1": "Active ingredients (in each gram) Purpose Bacitracin 400 units First aid antibiotic Neomycin 3.5 mg First aid antibiotic Polymyxin B 5,000 units First aid antibiotic", "Warnings": "For external use only.", "Directions": "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", "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° to 25°C (68° to 77° F) do not use if tube seal under cap is broken", "Active Ingredients": "Bacitracin zinc Neomycin sulfate Polymyxin B Sulfate", "Inactive ingredients": "mineral oil, petrolatum, water", "When Using this product": "use only as directed", "Stop use and ask a doctor if": "you need to use longer than 1 week condition persists or gets worse rash or other allergic reaction develops", "Ask a doctor before use if you have": "deep or puncture wounds animal bites serious burns"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:52.773138 · Updated: 2026-03-14T23:05:59.331876