FDA.reportPublic FDA data

EarClearRx

Manufacturer
Nuance Medical, LLC
Effective date
2021-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:10

Label at a glance#

ProductEarClearRx
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. Tilt head sideways, place 5-10 drops in the ear, tip of the applicator should not enter the ear canal. Keep drops in the 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 an ear irrigation sys...

Storage and handling

Do not store above 25°C (77°F).

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide USP 6.5%

USES

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

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

WARNINGS

WARNINGS SECTION

Ask a doctor before use if you have ear drainage, discharge, ear pain, irritation or rash in the ear, dizziness, had an injury or perforation of the ear drum. 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

FOR USE IN THE EAR ONLY. Tilt head sideways, place 5-10 drops in the ear, tip of the applicator should not enter the ear canal. Keep drops in the 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 an ear irrigation system.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Glycerin, Propylene Glycol, Sodium Bicarbonate, Lactic Acid, Purified Water

SPL UNCLASSIFIED SECTION

Children under 12 years of age: consult a doctor before use.

Other information

STORAGE AND HANDLING SECTION

Do not store above 25°C (77°F).

Question or Comments

OTC - QUESTIONS SECTION

(760) 362-8411

SPL UNCLASSIFIED SECTION

Distributed by: Nuance Medical LLC

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EARCLEAR Rx™

EAR WAX
REMOVAL
DROPS

Active ingredients:
Carbamide Peroxide USP 6.5%

0.5 FL OZ (15 mL)
NDC: 74318-102-05

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN1
702050carbamide peroxide 65 MG/ML Otic SolutionSCD1
702050carbamide peroxide 6.5 % Otic SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74318-102-052024-01-30C16284748780-11030e365-6b72-111a-e063-dadaa90a10e2EarClearRx™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74318-102-05EarClearRx15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74318-102EARCLEARRX (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [NUANCE MEDICAL, LLC]1Legacy NDC, 1 package rows20220101_8fa15a59-fb7b-4c88-a61d-0cf977a6e834.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
74318-10274318-102-05

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
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT

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
7de540a2-28f8-41fc-bf5e-289f520fec168fa15a59-fb7b-4c88-a61d-0cf977a6e8342021-11-12WarningsExact identifier
spl id: 7de540a2-28f8-41fc-bf5e-289f520fec16
spl set id: 8fa15a59-fb7b-4c88-a61d-0cf977a6e834

Reported adverse events (FAERS/openFDA)#

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