Thera Plus Original Strength Triple Antibiotic

Thera Plus Original Strength Triple Antibiotic
SPL v4
SPL
SPL Set ID 09e8bdb7-dc14-4f28-8306-c0e2bf73f081
Route
TOPICAL
Published
Effective Date 2024-11-26
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 Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-03

Description

Bacitracin zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic


Medication Information

Purpose

First aid antibiotic

Description

Bacitracin zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units

Uses

for first aid to help to prevent infection in minor:

  • cuts
  • scrapes
  • burns
Warnings

For external use only.

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) to affected area 1 to 3 times daily
  • May be covered with a sterile bandage.
  • Children under 2 years of age: ask a doctor before use
Do Not Use
  • if you are allergic to any of the ingredients in this product
  • in contact with the eyes or mucous membranes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor
Drug Facts

Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Other Information
  • store at room temperature 59° - 77°F (15° - 25°C).
Package Labeling:

Active Ingredients

Bacitracin zinc 400 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 units

Inactive Ingredients

mineral oil, petrolatum

When Using This Product
  • avoid contact with eyes
Stop Use and Ask A Doctor If
  • symptoms last for more than 7 days
  • the condition persists or gets worse
  • symptoms clear up and then occur again within a few days
  • a rash or other allergic reaction occurs
Keep Out of Reach of Children.

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

Ask A Doctor Before Use If You Have
  • deep or puncture wounds
  • animal bites
  • serious burns

Structured Label Content

Uses

for first aid to help to prevent infection in minor:

  • cuts
  • scrapes
  • burns
Purpose

First aid antibiotic

Warnings

For external use only.

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) to affected area 1 to 3 times daily
  • May be covered with a sterile bandage.
  • Children under 2 years of age: ask a doctor before use
Do Not Use (Do not use)
  • if you are allergic to any of the ingredients in this product
  • in contact with the eyes or mucous membranes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor
Drug Facts

Questions?

1-800-639-3803Weekdays 9 AM to 4 PM EST

Other Information (Other information)
  • store at room temperature 59° - 77°F (15° - 25°C).
Package Labeling:

Active Ingredients (Active ingredients)

Bacitracin zinc 400 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 units

Inactive Ingredients (Inactive ingredients)

mineral oil, petrolatum

When Using This Product (When using this product)
  • avoid contact with eyes
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • symptoms last for more than 7 days
  • the condition persists or gets worse
  • symptoms clear up and then occur again within a few days
  • a rash or other allergic reaction occurs
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).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • deep or puncture wounds
  • animal bites
  • serious burns

Advanced Ingredient Data


Raw Label Data

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