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

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)


Medication Information

Warnings

For external use only.

Uses
  • First aid to help prevent infection in minor cuts, scrapes, and burns
Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

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
Other Information

Store at room temperature

Inactive Ingredients

mineral oil, petrolatum, water

Description

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

Section 50565-1

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

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
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

Warnings

For external use only.

Uses
  • First aid to help prevent infection in minor cuts, scrapes, and burns
Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

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
Other Information

Store at room temperature

Inactive Ingredients

mineral oil, petrolatum, water

Section 50565-1 (50565-1)

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

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
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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