Triple Antibiotic
FDA Label NDC 27293-014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Budpak Inc. for the product Triple Antibiotic (NDC 27293-014). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active IngredientsBacitracin Zinc 400UNeomycin 3.5mg Polymyxin B sulfate 5000U

Otc - Purpose

PurposeFirst Aid AntibioticFirst Aid AntibioticFirst Aid Antibiotic

Indications & Usage

Uses  first aid to help prevent infection in   •minor cuts   •scrapes   •burns

Warnings

WarningsFor external use only

Otc - Do Not Use

Do not use  •in the eyes   •if you are allergic to any of the ingredients   •longer than 1 week unless directed by a doctor   •over large areas of the body

Otc - Ask Doctor

Ask a doctor before use on •on deep puncture wounds, animal bites, or serious burns

Otc - Stop Use

Stop use and consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops

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.

Dosage & Administration

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

Other

Other information•Store at 68 to 77F (20C-25C)  •See carton or tube crimp for lot number and expiration date

Inactive Ingredient

Inactive ingredients Petrolatum, Mineral oil, Ozocerite, Propanediol, Methylparaben, Propylparaben

Package Label.Principal Display Panel

Package Label

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