Active Ingredient
Carbamide Peroxide 6.5%
Clinere Ear Wax Remover Liquid
FDA Label NDC 68229-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quest Products for the product Clinere Ear Wax Remover (NDC 68229-102). 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 active ingredient, purpose, uses, warnings, ask a doctor before use if you have, when using this product, otc - stop use, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Earwax Removal Aid
Uses
For occassional use as an aid to soften, loosen and remove excess 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 eardrum
- recently had ear surgery
When Using This Product
avoid contact with the eyes.
Otc - Stop Use
Stop use and ask a Doctor if
- you need to use for more than four 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 5-10 drops into each ear canal.
- Tip of applicator should not enter ear canal.
- Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear.
- Use twice daily for up to four days if needed, or as directed by a doctor.
- Any wax remaining in the ear may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe, or by use of the included Clinere® ear cleaning tool. (See separate directions)
Children under 12 years: Consult a doctor.
Other Information
- Store at 15° - 30°C (59° - 86°F)
- Avoid exposing bottle to excessive heat or direct sunlight
- Store bottle in the outer carton
- Keep cap on bottle when not in use
- Product foams on contact with ear wax due to release of oxygen. There may be an associated crackling sound.
Inactive Ingredients
Anhydrous Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Water
Questions?
1-800-328-5890
Weekdays 8:30am -5:00pm CST
Clinere® Earwax Removal Kit W/4 Clinere® Ear Cleaners And 1 X 0.5 Fl Oz Carbamide Peroxide Bottle
102-02 (102 02)
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