Triple Antibiotic Ointment
FDA Label NDC 53329-087

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Triple Antibiotic (NDC 53329-087). 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 ingredient (in each gram), purpose, uses, warnings, do not use, stop use and ask a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (Equivalent to 3.5 mg. Neomycin)

Polymyxin B Sulfate 5000 units

Purpose

First Aid Antibiotic

Uses

First aid to help prevent infection in

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Do Not Use

  • in the eyes
  • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Stop Use And Ask A Doctor

  • in case of deep puncture wounds, animal bites or serious burns
  • if the condition persists or gets worse
  • if a rash or other allergic reaction develops

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 Information

  • Store at controlled room temperature 68°-77°F (20°-25°C)
  • Use only if packaging is intact

Inactive Ingredients

Petrolatum

Package/Label Principal Display Panel

NDC: 53329-087-01

CURAD

WE HELP HEAL

TRIPLE ANTIBIOTIC OINTMENT

first aid antibiotic

NET WT. 1 oz (28.4 g)

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