Harris Teeter Triple Antibiotic Plus Pain Relief
FDA Label NDC 72036-403

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter for the product Harris Teeter Triple Antibiotic Plus Pain Relief (NDC 72036-403). 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, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, indications & usage, 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)                                          Purpose

Neomycin 3.5 mg..................................................................First aid antibiotic

Polymyxin B 10,000 units.......................................................First aid antibiotic

Pramoxine HCI 10 mg............................................................External analgesic

Otc - Purpose

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

  • cuts
  • scrapes
  • burns

Warnings

Warnings

For external use only.

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - Stop Use

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
  • 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.

Indications & Usage

Directions

  • adults and children 2 years of age and older:
  • 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
  • children under 2 years of age: ask a doctor

Storage And Handling

Other information

  • store at 20° to 25°C (68° to 77°F)
  • lot no. & exp. date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

  • cetyl alcohol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, sorbitan monostearate, stearic acid, water

Dosage & Administration

Distributed by:

Harris Teeter, LLC

Matthews, NC 28105

Made in Korea

Package Label.Principal Display Panel

Image Description (72403.1)

Image Description (72403.1)

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