EARWAX REMOVAL KIT- carbamide peroxide liquid

Earwax Removal Kit by

Drug Labeling and Warnings

Earwax Removal Kit by is a Otc medication manufactured, distributed, or labeled by Lucid Wellness, Wisconsin Pharmacal Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

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)

Principal Display Panel

INGREDIENTS AND APPEARANCE

EARWAX REMOVAL KIT 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76928-1000
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	65 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TARTARIC ACID (UNII: W4888I119H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76928-1000-1	1 in 1 CARTON	05/18/2020
1		14.8 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

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)