Meijer Earwax Removal Kit Liquid
FDA Label NDC 41250-835
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc. for the product Meijer Earwax Removal Kit (NDC 41250-835). 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.
Label Section Quick Index
Active Ingredient
Carbamide peroxide 6.5%
Purpose
Earwax removal aid
Uses
for occasional use as an aid to soften, looser, and remove excessive earwax
Warnings
For use in the ear only
Ask A Doctor Before Use If You Have
- Ear drainage or discharge
- Ear pain
- Irritation, or rash in the ear
- Dizziness
- An injury or perforation (hole) of the ear drum
- Recently had ear surgery
When Using This Product
avoid contact with the eyes
Stop Use And Ask A Doctor If
- You need to use for more than 4 days
- Excessive earwax remains after use of this product
Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center right away.
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.
Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544 www.meijer.com
Package Label.Principal Display Panel
Meijer Washer Bulb Included Earwax Removal Kit Carbamide Peroxide 6.5% Earwax Removal Aid Safe and Effective 0.5 FL OZ (15 mL)
* Please review the disclaimer below.
