Triple Antibiotic Plus Pain Relief Ointment
FDA Label NDC 37835-904

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 Plus Pain Relief (NDC 37835-904). 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), purposes, uses, 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 10000 units

Pramoxine Hydrochloride 10 mg

Purposes

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

Uses

first aid to help prevent infection and for the temporary relief of pain in minor:

  • cuts
  • scrapes
  • burns

Warnings

  • For External Use Only

    • Do not use

    • if you are allergic to any of the ingredients
    • 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

        • you need to use longer than 1 week
        • condition persists or gets worse
        • symptoms persist for more than 1 week, or clear up and occur again within a few day
        • 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

Adults and children 2 years of age and older

  • clean 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

    • Children under 2 years of age:ask a doctor

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 20° to 25°C (68° to 77°F)
  • avoid excessive heat and humidity
  • 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 37835-904-01

Triple Antibiotic Ointment + Pain Relief

First Aid Antibiotic/Pain Relieving Ointment

Compare to the Active Ingredients in Neosporin ®+ Pain Relief *

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

Net. Wt. 1 oz (28.4 g)

Distributed by:

Bi-Mart

Eugene, OR 97402

Carton (Triple Antibiotic Plus Pain Relief)

Carton (Triple Antibiotic Plus Pain Relief)

* Please review the disclaimer below.