Thera Plus Original Strength Triple Antibiotic Ointment
FDA Label NDC 80684-140

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fourstar Group Usa, Inc. for the product Thera Plus Original Strength Triple Antibiotic (NDC 80684-140). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Bacitracin zinc 400 units

Neomycin sulfate 3.5 mg

Polymyxin B sulfate 5,000 units

Purpose

First aid antibiotic

Uses

for first aid to help to prevent infection in minor:

  • cuts
  • scrapes
  • burns

Warnings

For external use only.

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

When Using This Product

  • avoid contact with eyes

Ask A Doctor Before Use If You Have

  • deep or puncture wounds
  • animal bites
  • serious burns

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).

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

Other Information

  • store at room temperature 59° - 77°F (15° - 25°C).

Inactive Ingredients

mineral oil, petrolatum

Questions?

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