Quality Choice Earwax Removal Kit Liquid
FDA Label NDC 63868-026

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 Earwax Removal Kit (NDC 63868-026). 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 drug facts, active ingredient, purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts


Active Ingredient

Carbamide peroxide 6.5%

Uses

for occasional use as an aid to soften, looser, and remove excessive earwax

Warnings

For use in the ear only

Directions

FOR USE IN THE EAR ONLY
Adults and children over 12 years of age:

  • Tilt head sideways and place 5 to 10 drops into ear
  • Tip of applicator should not enter ear canal
  • Keep drops in ear for several minutes by keeping head titled or placing cotton in the ear
  • Use twice daily for up to 4 days if needed, or as directed by a doctor
  • Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe
  • Children under 12 years: consult a doctor

Other Information

  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Keep cap on bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound
  • Do not use if tamper-evident safety seal is broken or missing

Inactive Ingredients

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions?

1-800-328-5890

Other

*This product is not manufactured or distributed by Prestige Brands Inc. owner of the registered trademark Debrox.

Distributed by C.D.M.A., Inc.  43157 W. Nine Mile Novi, MI 48376-0995  www.qualitychoice.com  Questions: 248-449-9300

Package Label.Principal Display Panel

Quality Choice Earwax Removal Kit Earwax Removal aid  Carbamide Peroxide 6.5%  Safe, Gentle, Non-Irritating  Washer Bulb Included  0.5 FL OZ (15mL)

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