FDA Label for Harris Teeter Triple Antibiotic Plus Pain Relief

View Indications, Usage & Precautions

Harris Teeter Triple Antibiotic Plus Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Harris Teeter. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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