Family Care Triple Antibiotic Plus Pain Relief
FDA Label NDC 65923-523

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Triple Antibiotic Plus Pain Relief (NDC 65923-523). 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.

Otc - Active Ingredient

Active ingredients (in each gram)                                                   Purpose

Bacitracin 500 units....................................................................... First aid antibiotic

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

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

Pramoxine hydrochloride 10mg........................................................ First aid antibiotic

Otc - Purpose

Uses

first aid to help prevent infection and for temporarily 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
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • the condition persists or gets worse
  • rash or allerfic reaction develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

If swallowed, get medical help or contact Poison Control Center immediately

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 stearile bandage
  • children under 2 years of age: ask a doctor

Storage And Handling

Other information

  • store between 20° to 25°C (68° to 77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

ethanol, liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

Dosage & Administration

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos CA, 90703 USA

Made in Korea

Package Label.Principal Display Panel

Image Description (523)

Image Description (523)

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