Earwax Removal Kit
FDA Label NDC 76928-1000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lucid Wellness for the product Earwax Removal Kit (NDC 76928-1000). 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 - purpose, active ingredient, uses, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Purpose

→ Active Ingredient

→ Uses

→ Otc - Ask Doctor

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

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.