Active Ingredients (Each Gram Contains)
Bacitracin zinc 400 units
Neomycin sulfate 3.5 mg
Polymyxin B sulfate 5,000 units
Triple Antibiotic Ointment
FDA Label NDC 69571-888
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Front Pharmaceutical Plc for the product Triple Antibiotic (NDC 69571-888). 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 active ingredients (each gram contains), purpose, otc - keep out of reach of children, indications & usage, warnings, directions, inactive ingredient, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
First aid antibiotic
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Indications & Usage
Uses first aid to help prevent infection in minor:● cuts ● scrapes ● burns
Warnings
Warnings For external use only.
Do not use● in the eyes ● over large areas of the body
● if you are allergic to any of the ingredients.
Ask a doctor before use if you have
● deep or puncture wounds ● animal bites ● serious burns.
Stop use and ask a doctor if● condition persists or gets worse
● you need to use longer than 1 week
● a rash or other allergic reaction develops
Directions
● clean the affected area and dry thoroughly.
● 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.
Inactive Ingredient
Inactive ingredient Mineral Oil, White Petrolatum
Other Information
● store at 20° to 25°C ( 68° to 77°F)
Otc - Questions
Questions? Call 1-888-296-9067
Other
Distributed by:
Trifecta Pharmaceuticals USA®
Ft. Lauderdale, FL 33301, USA
1-888-296-9067
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