Triple Antibiotic
FDA Label NDC 71927-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Orazen Inc for the product Triple Antibiotic (NDC 71927-003). 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 Ingredients (in each gram)

Bacitracin Zinc         400 units

Neomycin Sulfate    5 mg

(3.5 mg of Neomycin base)

Polymyxin B Sulfate 5000 units

Otc - Purpose

Purpose

First aid antibiotic

Indications & Usage

Uses

first aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

Warnings

For 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 if you have deep or puncture wounds, animal bites, or serious burns

Otc - Stop Use

Stop use and ask a doctor if

  • the condition persists or gets worse
  • 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
  • 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 room temperature 20°C to 25°C (68°F to 77°C)
  • do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening

Inactive Ingredient

Inactive Ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment

Bacitracin Zinc, Neomycin Sulfate and Polymyxin B Sulfate

First Aid Antibiotic Ointment

NET WT 0.5 oz (14.2 g)

Image Of Package Label (Triple Antibiotic)

Image Of Package Label (Triple Antibiotic)

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