Triple Antibiotic Plus Pain Relief Ointment
FDA Label NDC 51672-2027

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun Pharmaceutical Industries, Inc. for the product Triple Antibiotic Plus Pain Relief (NDC 51672-2027). 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 - purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - 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

Otc - Purpose

Active ingredients (each gram contains)Purpose
Bacitracin zinc 500 unitsFirst aid antibiotic
Neomycin sulfate 3.5 mgFirst aid antibiotic
Polymyxin B sulfate 10,000 unitsFirst aid antibiotic
Pramoxine HCl 10 mgExternal analgesic

Uses

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

  • cuts
  • scrapes
  • burns

Warnings

For external use only.

Do Not Use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients.

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 days
  • 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.

Directions

Adults and children 2 years of age and older:

  • 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. Children under 2 years of age: ask a doctor

Other Information

  • To open: unscrew cap, pull tab to remove foil seal
  • store at 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredient

white petrolatum

Questions?

Call 1-866-923-4914

Principal Display Panel - 28.4 G Tube Label

First Aid Antibiotic
Pain Relieving Ointment

Maximum Strength
Triple Antibiotic
Ointment + Pain
Relief

Bacitracin Zinc ∙ Neomycin Sulfate
Polymyxin B Sulfate ∙ Pramoxine Hydrochloride

NET WT 1 oz (28.4 g)

Principal Display Panel (28.4 g Tube Label)

Principal Display Panel (28.4 g Tube Label)

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