Triple Antibiotic

SPL v5

SPL

SPL Set ID c3f80241-58ec-4608-8807-482ba8c91eef

Route

TOPICAL

Published

Effective Date 2012-10-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Bacitracin (400 U) Neomycin (3.5 mg) Polymyxin B (5000 U)

Inactive Ingredients

Mineral Oil Squalane Lanolin Petrolatum .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2012-09-26

Description

Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units

Purpose

First aid antibiotic

Medication Information

Purpose

First aid antibiotic

Description

Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units

Uses

First aid to help prevent infection in minor:

cuts
scrapes
burns

Purposes

First aid antibiotic

Warnings

For external use only

Do not use if you are allergic to any of the ingredients

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

Package Label

NDC NO. 53210-1004-0

First Aid Prevent Infection

Cuts Scrapes Burns

Maximum Strength

Help Prevent Infection in Minor Cuts, Scrapes and Burns

Soothing Ointment

Original

TRIPLE ANTIBIOTIC

Polymyxin B Sulfate-Bacitracin Zinc-Neomycin Sulfate

Net 1 oz(28.3g)

Exclusively distributed by:

Morales Distributors, Inc

Mayaguez, P.R. 00682

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Original Neosporin (R)

Made in Korea

Other Information

store at 59 degrees to 77 degrees Fahrenheit

Inactive Ingredients

Liquid paraffin, Cethanol, Squalane, Lanolin, Petrolatum, Tocopheryl acetate

When Using This Product

do not use in the eyes
do not apply over large areas of the body

Stop Use and Ask A Doctor If

you need to use more 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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Ask A Doctor Before Use If You Have

serious burns
deep or puncture wounds
animal bites

Structured Label Content

Uses

First aid to help prevent infection in minor:

cuts
scrapes
burns

Purposes

First aid antibiotic

Warnings

For external use only

Do not use if you are allergic to any of the ingredients

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

Package Label (Package label)

NDC NO. 53210-1004-0

First Aid Prevent Infection

Cuts Scrapes Burns

Maximum Strength

Help Prevent Infection in Minor Cuts, Scrapes and Burns

Soothing Ointment

Original

TRIPLE ANTIBIOTIC

Polymyxin B Sulfate-Bacitracin Zinc-Neomycin Sulfate

Net 1 oz(28.3g)

Exclusively distributed by:

Morales Distributors, Inc

Mayaguez, P.R. 00682

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Original Neosporin (R)

Made in Korea

Other Information (Other information)

store at 59 degrees to 77 degrees Fahrenheit

Inactive Ingredients (Inactive ingredients)

Liquid paraffin, Cethanol, Squalane, Lanolin, Petrolatum, Tocopheryl acetate

When Using This Product (When using this product)

do not use in the eyes
do not apply over large areas of the body

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you need to use more 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

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.

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

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

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

serious burns
deep or puncture wounds
animal bites

Advanced Ingredient Data

[{"name": "BACITRACIN", "unii": "58H6RWO52I", "classCode": "ACTIM", "strengthNumerator": "400", "strengthDenominator": "1", "strengthNumeratorUnit": "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": "U", "strengthDenominatorUnit": "g"}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SQUALANE", "unii": "GW89575KF9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "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", "Purposes": "First aid antibiotic", "Warnings": "For external use only Do not use if you are allergic to any of the ingredients", "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", "Package label": "NDC NO. 53210-1004-0 First Aid Prevent Infection Cuts Scrapes Burns Maximum Strength Help Prevent Infection in Minor Cuts, Scrapes and Burns Soothing Ointment Original TRIPLE ANTIBIOTIC Polymyxin B Sulfate-Bacitracin Zinc-Neomycin Sulfate Net 1 oz(28.3g) Exclusively distributed by: Morales Distributors, Inc Mayaguez, P.R. 00682 This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Original Neosporin (R) Made in Korea", "Other information": "store at 59 degrees to 77 degrees Fahrenheit", "Inactive ingredients": "Liquid paraffin, Cethanol, Squalane, Lanolin, Petrolatum, Tocopheryl acetate", "When using this product": "do not use in the eyes do not apply over large areas of the body", "Stop use and ask a doctor if": "you need to use more 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", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Active ingredients (in each gram)": "Bacitracin Zinc 400 units Neomycin Sulfate 3.5mg Polymyxin B Sulfate 5,000 units", "Ask a doctor before use if you have": "serious burns deep or puncture wounds animal bites"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:31.910530 · Updated: 2026-03-14T22:53:17.603568