Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 57ed1a03-7e1b-4eb4-8001-dfd118805edc
Route
TOPICAL
Published
Effective Date 2024-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (0.0035 g) Polymyxin B (5000 [USP'U])
Inactive Ingredients
Mineral Oil White Petrolatum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-16

Description

Bacitracin Zinc (Bacitracin 400 Units) Neomycin Sulfate (Neomycin 3.5mg) Polymyxin B Sulfate (Polymyxin B 5,000 Units)

Purpose

First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Description

Bacitracin Zinc (Bacitracin 400 Units) Neomycin Sulfate (Neomycin 3.5mg) Polymyxin B Sulfate (Polymyxin B 5,000 Units)

Uses
  • First aid to help prevent infection in minor cuts, scrapes, and burns
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center directly.

Warnings

For external use only.

Directions
  • clean affected area
  • apply small amount of this product (an amount equal to the surface of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage
Do Not Use
  • in eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Other Information

Store at room temperature

Inactive Ingredients

mineral oil, petrolatum, water

Stop Use and Ask A Doctor If
  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Active Ingredients (in Each Gram)

Bacitracin Zinc (Bacitracin 400 Units)

Neomycin Sulfate (Neomycin 3.5mg)

Polymyxin B Sulfate (Polymyxin B 5,000 Units)

Ask A Doctor If Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel – 0.90ml Pouch Label

BE SMART

GET PREPARED®

TRIPLE ANTIBIOTIC OINTMENT

0.03 oz [0.90 g]

Single Use

Made in China

Manufactured for Total Resources Intl. Inc.

Walnut, California 91789

www.besmartgetprepared.com00-OIN-21224COM Rev. 00

NDC 55550-451-01


Structured Label Content

Uses
  • First aid to help prevent infection in minor cuts, scrapes, and burns
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center directly.

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Warnings

For external use only.

Directions
  • clean affected area
  • apply small amount of this product (an amount equal to the surface 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)
  • in eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor
Other Information

Store at room temperature

Inactive Ingredients

mineral oil, petrolatum, water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the condition persists or gets worse
  • a rash or other allergic reaction develops
Active Ingredients (in Each Gram) (Active Ingredients (in each gram))

Bacitracin Zinc (Bacitracin 400 Units)

Neomycin Sulfate (Neomycin 3.5mg)

Polymyxin B Sulfate (Polymyxin B 5,000 Units)

Ask A Doctor If Before Use If You Have (Ask a doctor if before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns
Principal Display Panel – 0.90ml Pouch Label (Principal Display Panel – 0.90mL Pouch Label)

BE SMART

GET PREPARED®

TRIPLE ANTIBIOTIC OINTMENT

0.03 oz [0.90 g]

Single Use

Made in China

Manufactured for Total Resources Intl. Inc.

Walnut, California 91789

www.besmartgetprepared.com00-OIN-21224COM Rev. 00

NDC 55550-451-01


Advanced Ingredient Data


Raw Label Data

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