Triple Antibiotic Ointment + Lidocaine

Triple Antibiotic Ointment + Lidocaine
SPL v4
SPL
SPL Set ID 14fda967-54ba-c964-e063-6294a90a21ee
Route
TOPICAL
Published
Effective Date 2025-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (500 [USP'U]) Neomycin (3.5 mg) Polymyxin B (10000 [USP'U]) Lidocaine (40 mg)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-31

Description

Bacitracin zinc 500 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 10,000 units

Purpose

First aid antibiotic


Medication Information

Purpose

First aid antibiotic

Description

Bacitracin zinc 500 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 10,000 units

Uses

Uses first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:● cuts ● scrapes ● burns

Label

Warnings

For external use only.

Questions

Questions? Call 1-888-296-9067

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
Do Not Use

Do Not Use

  • If you are allergic to any of the ingredients
  • In the eyes
  • Over large areas of the body
  • In large quantities, particularly over raw surfaces or blistered areas
Package Label

Package Label

Distributed By

Distributed by:

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301, USA

1-888-296-9067

* This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin® plus Lidocaine

Lidocaine known to numb in 30 to 60 minutes.

Active Ingredient

Lidocaine 40mg

Other Information



● store at 20° to 25°C ( 68° to 77°F)

Inactive Ingredient

Petrolatum

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
  • 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.

Ask Doctor Before Use If You Have

Ask Doctor before use if you have

  • Deep or puncture wounds
  • Animal bites
  • serious burns
Active Ingredients (each Gram Contains)

Bacitracin zinc 500 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 10,000 units


Structured Label Content

Uses

Uses first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:● cuts ● scrapes ● burns

Label

Purpose

First aid antibiotic

Warnings

For external use only.

Questions

Questions? Call 1-888-296-9067

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
Do Not Use

Do Not Use

  • If you are allergic to any of the ingredients
  • In the eyes
  • Over large areas of the body
  • In large quantities, particularly over raw surfaces or blistered areas
Package Label (PACKAGE LABEL)

Package Label

Distributed By

Distributed by:

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301, USA

1-888-296-9067

* This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin® plus Lidocaine

Lidocaine known to numb in 30 to 60 minutes.

Active Ingredient

Lidocaine 40mg

Other Information (Other information)



● store at 20° to 25°C ( 68° to 77°F)

Inactive Ingredient

Petrolatum

Stop Use and Ask A Doctor If (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
  • 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)

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

Ask Doctor Before Use If You Have (Ask Doctor Before use if you have)

Ask Doctor before use if you have

  • Deep or puncture wounds
  • Animal bites
  • serious burns
Active Ingredients (each Gram Contains) (Active ingredients (each gram contains))

Bacitracin zinc 500 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 10,000 units


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)