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 68016-319
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Premier Value Alliance Llc. for the product Triple Antibiotic (NDC 68016-319). 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, inactive ingredient, other information, otc - questions, 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 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
Inactive Ingredient
Inactive ingredient:Cetyl Alcohol, Light Mineral Oil, Squalane, Stearic Acid, Vitamin E and 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.
Distributed By:
Pharmacy Value Alliance, LLC.
407 East Lancaster Avenue, Wayne, PA. 19087
Product of PRC
If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
Otc - Questions
Questions? Call 1-866-923-4914
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.
* Please review the disclaimer below.
