FDA Label for Earwax Removal Kit
View Indications, Usage & Precautions
Earwax Removal Kit Product Label
The following document was submitted to the FDA by the labeler of this product Lucid Wellness. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
Earwax removal aid
Active Ingredient
Active ingredient | Purpose |
Carbamide peroxide 6.5% | Earwax removal aid |
Uses
For occasional use as an aid to soften, loosen, and remove excessive earwax.
Otc - Ask Doctor
Ask a doctor before use if you have ■ ear drainage or discharge ■ ear pain ■ irritation or rash in the ear ■ dizziness ■ an injury or per1oration (hole) of the eardrum ■ recently had ear surgery.
Otc - When Using
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center immediately.
Directions
FOR USE IN THE EAR ONLY Adults and children over 12 years of age: ■ tilt head sideways ■ 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 tilted or placing cotton in the ear ■ use twice daily for up to four 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
■ store bottle in the outer carton. ■ product foams on contact with earwax due to release of oxygen. There may be an associated "cracking" sound. ■ keep cap on bottle when not in use.
Inactive Ingredients
Glycerin, Polysorbate 20, Propylene glycol, Sodium citrate, Tartaric acid
Questions Or Comments?
(496) 845-2722
Principal Display Panel
Lucid Wellness™
EARWAX
REMOVAL KIT™
Effectively removes
excessive buildup
with fast foaming acion
— CARBAMIDE PEROXIDE 6.5%
Kit includes:
Soft BulbSyringe and Drops
EASY | EFFECTIVE | SAFE
NET WT. 0.5 FL OZ (14.8 mL)
* Please review the disclaimer below.