Quality Choice Triple Antibiotic
FDA Label NDC 63868-356

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Quality Choice Triple Antibiotic (NDC 63868-356). 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                                                            Purpose

Bacitracin zinc 400 units................................................ First aid antibiotic

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

Polymyxin B sulfate 5,000 units...................................... First aid antibiotic

Otc - Purpose

Uses

first aid to help prevent infection in mirror:

  • 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 the large areas of the body

Otc - Ask Doctor

Ask 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
  • 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

  • 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

Storage And Handling

Other information

  • store at 20° to 25°C (68° to 77°F)
  • Lot & Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

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

Dosage & Administration

DISTRIBUTED BY:

C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376-0995

www.qualitychoice.com

MADE IN KOREA

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