Thera Plus Original Strength Triple Antibiotic Ointment
FDA Label NDC 80684-198
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 80684-198). 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 (in each gram), 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
Active Ingredients (In Each Gram)
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 conditions persists or gets worse • symptoms clear up and the 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
white petrolatum
Questions?
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Package Labeling:
Label2 (Label2)
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