Quality Choice Maximum Strength Triple Antibiotic
FDA Label NDC 63868-910

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 Maximum Strength Triple Antibiotic (NDC 63868-910). 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

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

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

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

Pramoxine hydrochloride 10 mg.............................................. First aid analgesic

Otc - Purpose

Uses

Helps prevent infection and temporarily relieves pains 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 Poision Control Center right away.

Indications & Usage

Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • apply a small amount equal to surface area of a finger tip, on 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 crimp or tube

Inactive Ingredient

Inactive ingredients

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

Dosage & Administration

DISTRIBUTED BY:

C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376-0995 USA

Made in Korea

Package Label.Principal Display Panel

Image Description (94594.1)

Image Description (94594.1)

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