FDA.reportPublic FDA data

Ear Wax Removal System

Manufacturer
Rite Aid | Product Quest Mfg
Effective date
2018-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:53

Label at a glance#

ProductEar Wax Removal System Rite Aid
Active ingredientCarbamide Peroxide
Label structure4 sections

Indications and uses

for occasional use as an aid to soften, loosen and remove excessive ear wax

Label contents#

Full prescribing information#

Active ingredient                              Purpose

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide - 6.50%             Earwax removal aid

Uses

INDICATIONS & USAGE SECTION

for occasional use as an aid to soften, loosen and remove excessive ear wax

WarningsFor external use only

WARNINGS SECTION

Keep out of reach of the children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions For use in the ear only.Adults and children over 12 years of age:

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

• Protect from heat and direct sunlight • Keep cup on bottle when not in use

Inactive ingredient

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract
Chamomilla Recutita (Matricaria) Flower Extract
Glycerin
Mineral Oil
Oxyquinoline Sulfate
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

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
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-1225-72020-01-31C16284748780-19d75b9d0-7e7f-f424-e053-dadaa90a57ceDrug Facts Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1225-7Ear Wax Removal SystemRite Aid1 in 1 KITKIT11
11822-1226-1Ear Wax Removal SystemRite Aid15 mL in 1 BOTTLESOLUTION/ DROPS15 mL6.5 g in 100mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1225EAR WAX REMOVAL SYSTEM RITE AID (CARBAMIDE PEROXIDE - 6.50%) KIT [RITE AID]1Legacy NDC, 2 package rows20180613_0a7e2ef1-14a0-44b0-a9ca-0db89b8efbc4.zip
11822-1226EAR WAX REMOVAL SYSTEM RITE AID (CARBAMIDE PEROXIDE - 6.50%) KIT [RITE AID]1Unmatched20180613_0a7e2ef1-14a0-44b0-a9ca-0db89b8efbc4.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-122611822-1226-1
11822-122511822-1225-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Carbamide Peroxide31PZ2VAU81ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CHAMOMILEFGL3685T2XIACT
GlycerinPDC6A3C0OXIACT
Oxyquinoline Sulfate61VUG75Y3PIACT
Mineral OilT5L8T28FGPIACT
WATER059QF0KO0RIACT

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
3f3b722a-07e0-40eb-8c19-16a8f21370110a7e2ef1-14a0-44b0-a9ca-0db89b8efbc42018-06-13WarningsExact identifier
spl id: 3f3b722a-07e0-40eb-8c19-16a8f2137011
spl set id: 0a7e2ef1-14a0-44b0-a9ca-0db89b8efbc4

Reported adverse events (FAERS/openFDA)#

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