Tilcare EARWAX REMOVAL AID EAR DROPS

Manufacturer
Tilco Trading Pte. Ltd.
Effective date
2021-01-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:23

Label at a glance#

ProductTilcare
Active ingredientCARBAMIDE PEROXIDE
Label structure11 sections

Dosage and administration

FOR USE IN THE EAR ONLY. •  adults and children over 12 years of age: tilt head sideways and 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 4 days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm ...

Storage and handling

• tamper evident: Do not use if outer carton is open, torn or missing. • store bottle in the outer carton and keep the tip on bottle when not in use •  store at 20-25°C (68-77°F) •  drops foam in contact with earwax due to release of oxygen. You may experience a “crackling” sound

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carbamide peroxide 6.5%

Purpose

OTC - PURPOSE SECTION

Earwax removal aid

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

• if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor.

• if you have an injury or perforation (hole) of the ear drum or after ear surgery unless directed by a doctor.

• for more than four days.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

FOR USE IN THE EAR ONLY.

• adults and children over 12 years of age: tilt head sideways and 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 4 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 of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

• tamper evident: Do not use if outer carton is open, torn or missing.

• store bottle in the outer carton and keep the tip on bottle when not in use

• store at 20-25°C (68-77°F)

• drops foam in contact with earwax due to release of oxygen. You may experience a “crackling” sound

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Lauroyl Sarcosine, Propylene Glycol

Questions?

OTC - QUESTIONS SECTION

+1-844-324-5669

You may also report serious side effects to this phone number.

SPL UNCLASSIFIED SECTION

Gently Removes Excessive Earwax

Safe & Easy to Use

Dist. by: Tilco Trading PTE. LTD. 491B River Valley Road #15-01, Valley Point, Singapore - 248373
Made in USA
www.tilcare.com / customers@tilcare.com

Carbamide peroxide 6.5%

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ear dropsEar drops

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN3
702050carbamide peroxide 65 MG/ML Otic SolutionSCD3
702050carbamide peroxide 6.5 % Otic SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73390-101-152024-01-30C16284748780-11030e365-6045-111a-e063-dadaa90a10e2Tilcare EARWAX REMOVAL AID EAR DROPS
73390-101-202024-01-30C16284748780-11030e365-6045-111a-e063-dadaa90a10e2Tilcare EARWAX REMOVAL AID EAR DROPS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73390-101-14Tilcare15 mL in 1 BOTTLESOLUTION/ DROPS153
73390-101-15Tilcare1 in 1 BOXSOLUTION/ DROPS13
73390-101-20Tilcare2 in 1 BOXSOLUTION/ DROPS23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73390-101TILCARE (CARBAMIDE PEROXIDE) SOLUTION/ DROPS [TILCO TRADING PTE. LTD.]3Legacy NDC, 3 package rows20210127_c3067dbd-0fc4-4405-ba1d-fe09010bf89e.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73390-10173390-101-14, 73390-101-15, 73390-101-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
227b98c4-4a7f-4c25-afa3-dc701883ebc4c3067dbd-0fc4-4405-ba1d-fe09010bf89e2021-01-25WarningsExact identifier
spl id: 227b98c4-4a7f-4c25-afa3-dc701883ebc4
spl set id: c3067dbd-0fc4-4405-ba1d-fe09010bf89e

Reported adverse events (FAERS/openFDA)#

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