Triple Antibiotic Plus Pain Relief Ointment
FDA Label NDC 83324-264

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc. for the product Triple Antibiotic Plus Pain Relief (NDC 83324-264). 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, active ingredient, otc - keep out of reach of children, indications & usage, warnings, directions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Each Gram Contains)

Bacitracin zinc 500 units



Neomycin sulfate 3.5 mg



Polymyxin B sulfate 10,000 units

Purpose

First aid antibiotic

External Analgesic

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

WarningsFor external use only.

Do not use● in the eyes ● over large areas of the body

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: 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 crimp for lot number and expiration date.

Distributed by C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

questions: 800-935-2362

Product of PRC

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