american sales company triple antibiotic ointment drug facts

SPL v5

SPL

SPL Set ID 09a0b0b9-1806-4ff9-80fa-448dabbf2cc7

Route

topical

Published

Effective Date 2024-09-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

bacitracin (400 [USP'U]) neomycin (3.5 mg) polymyxin b (5000 [USP'U])

Inactive Ingredients

petrolatum cocoa butter cottonseed oil olive oil sodium pyruvate .alpha.-tocopherol acetate

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph drug active Since 2019-10-01

Purpose

First aid antibiotic

Description

Bacitracin zinc equivalent to 400 units bacitracin Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 5,000 units as polymyxin B sulfate

Medication Information

Warnings

For external use only.

Uses

first aid to help prevent infection in minor:

•
cuts
•
scrapes
•
burns

Purpose

First aid antibiotic

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

Other Information

•
store at 20-25°C (68-77°F)

Inactive Ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum

Description

Bacitracin zinc equivalent to 400 units bacitracin Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 5,000 units as polymyxin B sulfate

Do Not Use

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

Questions Or Comments?

1-800-719-9260

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Active Ingredients (in Each Gram)

Bacitracin zinc equivalent to 400 units bacitracin

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 5,000 units as polymyxin B sulfate

Ask A Doctor Before Use If You Have

•
deep or puncture wounds
•
animal bites
•
serious burns

Package/label Principal Display Panel

Compare to the active ingredients in Neosporin^®

Original Strength

Triple Antibiotic Ointment

Long Lasting Infection Protection

First Aid Antibiotic Ointment

Helps skin heal to look healthy

Bacitracin Zinc – Neomycin Sulfate – Polymyxin B Sulfate

OUR PHARMACISTS RECOMMEND

NET WT .5 OZ (14g)

Structured Label Content

Warnings

For external use only.

Uses

first aid to help prevent infection in minor:

•
cuts
•
scrapes
•
burns

Purpose

First aid antibiotic

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

Other Information (Other information)

•
store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum

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 Or Comments? (Questions or comments?)

1-800-719-9260

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

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. (1-800-222-1222)

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

Bacitracin zinc equivalent to 400 units bacitracin

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 5,000 units as polymyxin B sulfate

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

•
deep or puncture wounds
•
animal bites
•
serious burns

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to the active ingredients in Neosporin^®

Original Strength

Triple Antibiotic Ointment

Long Lasting Infection Protection

First Aid Antibiotic Ointment

Helps skin heal to look healthy

Bacitracin Zinc – Neomycin Sulfate – Polymyxin B Sulfate

OUR PHARMACISTS RECOMMEND

NET WT .5 OZ (14g)

Advanced Ingredient Data

[{"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "400", "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": "5000", "strengthDenominator": "1", "strengthNumeratorUnit": "[USP'U]", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCOA BUTTER", "unii": "512OYT1CRR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COTTONSEED OIL", "unii": "H3E878020N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLIVE OIL", "unii": "6UYK2W1W1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PYRUVATE", "unii": "POD38AIF08", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "first aid to help prevent infection in minor: • cuts • scrapes • burns", "Purpose": "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 20-25°C (68-77°F)", "Inactive ingredients": "cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum", "Questions or comments?": "1-800-719-9260", "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", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "Active ingredients (in each gram)": "Bacitracin zinc equivalent to 400 units bacitracin Neomycin sulfate equivalent to 3.5 mg of neomycin base Polymyxin B 5,000 units as polymyxin B sulfate", "Ask a doctor before use if you have": "• deep or puncture wounds • animal bites • serious burns", "Package/Label Principal Display Panel": "Compare to the active ingredients in Neosporin ® Original Strength Triple Antibiotic Ointment Long Lasting Infection Protection First Aid Antibiotic Ointment Helps skin heal to look healthy Bacitracin Zinc – Neomycin Sulfate – Polymyxin B Sulfate OUR PHARMACISTS RECOMMEND NET WT .5 OZ (14g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:35.727864 · Updated: 2026-03-14T23:03:46.018464