Triple Antibiotic Ointment
FDA Label NDC 37835-903

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Triple Antibiotic (NDC 37835-903). 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 (in each gram), purpose, use(s), warnings, otc - keep out of reach of children, directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (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

Use(S)

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

  • For External Use Only

    • Do not use

    • in the eyes or apply over large areas of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week unless directed by a doctor

      • Ask a doctor before use if you havedeep or puncture wounds, animal bites, or serious burns

      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 (1-800-222-1222) right away.

Directions

Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of th tip of a finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.

Other Information

  • Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
  • Store at room temperatue between 15-30°C (59-86°F)
  • Preserve in well-closed containers
  • See crimp of tube or carton for Lot Number and Expiry Date

Inactive Ingredient

White Petrolatum

Questions Or Comments?

Call 1-800-935-6737

Principal Display Panel

NDC 37835-903-01

Triple Antibiotic Ointment

First aid antibiotic

Compare to the Active Ingredients in Neosporin ®*

*This product is not manufactured or distributed by Johnson & Johnson Corporation Products Company, Inc, owner of the registered trademark Neosporin ®.

Net. Wt. 1 oz (28.4 g)

Distributed by:

Bi-Mart

Eugene, OR 97402

Carton (Triple Antibiotic)

Carton (Triple Antibiotic)

* Please review the disclaimer below.