Earwax Removal Kit: Package Insert and Label Information

EARWAX REMOVAL KIT- carbamide peroxide liquid
Lucid Wellness

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Earwax removal aid

Drug Facts

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.

Warnings

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.

When using this product avoid contact with the eyes.

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 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)

Carton
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Principal Display Panel

LABEL
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EARWAX REMOVAL KIT
carbamide peroxide liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76928-1000
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE 65 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
TARTARIC ACID
GLYCERIN
PROPYLENE GLYCOL
SODIUM CITRATE
POLYSORBATE 20
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76928-1000-1 1 BOTTLE, DISPENSING in 1 CARTON contains a BOTTLE, DISPENSING
1 14.8 mL in 1 BOTTLE, DISPENSING This package is contained within the CARTON (76928-1000-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 05/18/2020
Labeler — Lucid Wellness (117497048)
Registrant — Wisconsin Pharmacal Company (800873986)

Revised: 01/2022 Lucid Wellness

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