Quality Choice Triple Antibiotic Plus Pain Reliever
FDA Label NDC 63868-945

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 Plus Pain Reliever (NDC 63868-945). 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, warnings, otc - do not use, otc - ask doctor, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Uses

help prevent infection and temporarily relieves pain due to

  • minor cuts
  • scrapes
  • burns

Warnings

Warnings

For external use only

Allergy alert: do not use if allergic to any of the ingredients

Otc - Do Not Use

Do not use

  • in or near the eyes
  • over large areas of the body
  • longer than 1 week

Otc - Ask Doctor

Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

Otc - Stop Use

Stop use and ask a doctor if

  • condition persists or gets worse
  • symptoms last for more than 7 days or clear up and comes back within a few days
  • a rash or other allergic reaction occurs

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 and older:

  • clean affected area
  • apply a small amount (equal to the surface area of the tip of a finger) on area 1 to 3 times daily
    • may be covered with a sterile bandage   
      • Children under 2 years: ask a doctor

Storage And Handling

Other information

  • store at 15o to 25o C (59o to 77o F)
  • Lot No. and Exp. Date: see box or crimp of tube

Inactive Ingredient

Inactive ingredients

white petrolatum, Polysorbate 80, Stearic acid polyoxil 40, Methylparaben, Propylparaben, Purified Water

Dosage & Administration

Distributed By Quality Choice

NOVI, MI 48376-0995

MADE IN KOREA

QC 94594

www.chaindrug.com

Package Label.Principal Display Panel

Image Of Carton Label (Qctripleantibioticplus)

Image Of Carton Label (Qctripleantibioticplus)

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Otc - Active Ingredient

Active Ingredients (in each gram)                                                                      Purpose

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

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

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

Pramoxine hydrochloride 10 mg........................................................................Pain reliever

* Please review the disclaimer below.