FDA.reportPublic FDA data

Earwax Removal Kit

Manufacturer
Lucid Wellness | Wisconsin Pharmacal Company
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:45

Label at a glance#

ProductEarwax Removal Kit
Active ingredientCARBAMIDE PEROXIDE
Label structure10 sections

Indications and uses

For occasional use as an aid to soften, loosen, and remove excessive earwax.

Dosage and administration

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 w...

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Earwax removal aid

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredientPurpose
Carbamide peroxide 6.5%Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

For occasional use as an aid to soften, loosen, and remove excessive earwax.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

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 SECTION

When using this product avoid contact with the eyes.

OTC - STOP USE SECTION

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 SECTION

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

Glycerin, Polysorbate 20, Propylene glycol, Sodium citrate, Tartaric acid

Questions or comments?

OTC - QUESTIONS SECTION

(496) 845-2722

Principal Display Panel

PACKAGE LABEL.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)

CartonCarton

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76928-1000-12024-01-30C16284748780-11030e365-6681-111a-e063-dadaa90a10e2Lucid Wellness™ Earwax Removal Kit™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76928-1000-1Earwax Removal Kit14.8 mL in 1 BOTTLE, DISPENSINGLIQUID14.82
76928-1000-1Earwax Removal Kit1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76928-1000EARWAX REMOVAL KIT (CARBAMIDE PEROXIDE) LIQUID [LUCID WELLNESS]2Legacy NDC, 2 package rows20220114_a61f807e-5c51-023f-e053-2995a90a5b9c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76928-100076928-1000-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TARTARIC ACIDW4888I119HIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CITRATE1Q73Q2JULRIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
POLYSORBATE 207T1F30V5YHIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d57c21a5-c79a-0c91-e053-2a95a90a045ca61f807e-5c51-023f-e053-2995a90a5b9c2022-01-13WarningsExact identifier
spl id: d57c21a5-c79a-0c91-e053-2a95a90a045c
spl set id: a61f807e-5c51-023f-e053-2995a90a5b9c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.