Premier Value Triple Antibiotic Ointment
FDA Label NDC 68016-320

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 Premier Value Triple Antibiotic (NDC 68016-320). 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.

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

Inactive Ingredient

Inactive ingredient:Mineral Oil 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

* Please review the disclaimer below.