FDA.reportPublic FDA data

EAR WAX RMVL

Manufacturer
Rite Aid | Pharma Nobis, LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:04:38

Label at a glance#

ProductEAR WAX RMVL Rite Aid
Active ingredientCARBAMIDE PEROXIDE
Label structure6 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active ingredient                        Purpose

OTC - ACTIVE INGREDIENT SECTION

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


Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

OTC - WHEN USING SECTION

When using this product avoid contact with 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 the children
If product is swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions 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.

INACTIVE INGREDIENT SECTION

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

Rite Aid Earwax Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rite Aid Earwax Carton 12-30-22Rite Aid Earwax Carton 12-30-22Rite Aid Earwax Label 12-30-22Rite Aid Earwax Label 12-30-22RAWax.jpgRAWax.jpgRite Aid Earwax Kit.jpgRite Aid Earwax Kit.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702050carbamide peroxide 6.5 % Otic SolutionPSN5
702050carbamide peroxide 65 MG/ML Otic SolutionSCD5
702050carbamide peroxide 6.5 % Otic SolutionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1224-1EAR WAX RMVLRite Aid15 mL in 1 BOTTLELIQUID155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1224EAR WAX RMVL RITE AID (CARBAMIDE PEROXIDE 6.5%) LIQUID [RITE AID]5Current NDC, Legacy NDC, 1 package rows20231216_9e3cedcc-e523-2653-e053-2a95a90ad143.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-122411822-1224-1

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
PROPYLENE GLYCOL6DC9Q167V3IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
SODIUM STANNATENJ7C1V83KGIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EAR WAX RMVL Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aid9e3cedcc-e523-2653-e053-2a95a90ad1432023-12-15WarningsExact identifier
ndc (package): 11822-1224-1
ndc (product): 11822-1224
ndc11 (package): 11822122401
spl id: 0c93bf8d-eab3-1947-e063-6394a90acc0f
spl set id: 9e3cedcc-e523-2653-e053-2a95a90ad143
EarWax Removal Kit Rite AidCARBAMIDE PEROXIDE 6.5%Rite Aidda78ac58-6c1c-4fa9-baac-e9dec02413852023-12-15WarningsExact identifier
ndc (package): 11822-1224-1
ndc11 (package): 11822122401

Reported adverse events (FAERS/openFDA)#

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