FDA Label for Triple Antibiotic
View Indications, Usage & Precautions
Triple Antibiotic Product Label
The following document was submitted to the FDA by the labeler of this product Trifecta Pharmaceuticals Usa Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients (Each Gram Contains)
Bacitracin zinc 400 units
Neomycin sulfate 3.5 mg
Polymyxin B sulfate 5,000 units
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 right away.
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 light Mineral Oil, White Petrolatum
Other Information
● To open: unscrew cap, pull tab to remove foil seal
● store at 20° to 25°C ( 68° to 77°F)
● see carton or tube for lot number and expiration date.
Otc - Questions
Questions? Call 1-888-296-9067
Other
Distributed by:
Trifecta Pharmaceuticals USA™
101 NE Third Avenue, Suite 1500
Ft. Lauderdale, FL 33301, USA
1-888-296-9067
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