FDA.reportPublic FDA data

Rite Aid Earwax Removal Drops

Manufacturer
Rite Aid | Derma Care Research Labs, LLC
Effective date
2024-05-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:16

Label at a glance#

ProductRite Aid Earwax Removal Drops
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Carbamide Peroxide 6.5%

OTC - PURPOSE SECTION

Earwax removal aid

INDICATIONS & USAGE SECTION

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

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 eardrum or after ear surgery unless directed by a doctor
  • for more than 4 days; if excessive earwax remains after use of this product, consult a doctor

When using this product avoid contact with the eyes. If accidental contact with the eyes occurs, flush your eyes with water and consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

FOR IN EAR USE 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, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonCartonCarton

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130011822897228GTIN-13: 0011822897228
EAN-13: 0011822897228
GTIN-12: 011822897228
UPC-A: 011822897228
GTIN storage (14 digits): 00011822897228		Rite Aid_Earwax Removal Drops_Temp copy.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-6117-0Rite Aid Earwax Removal Drops15 mL in 1 BOTTLELIQUID151
11822-6117-0Rite Aid Earwax Removal Drops1 in 1 CARTONLIQUID11
11822-6117-1Rite Aid Earwax Removal Drops15 mL in 1 BOTTLE, PLASTICLIQUID151
11822-6117-1Rite Aid Earwax Removal Drops1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-6117RITE AID EARWAX REMOVAL DROPS (CARBAMIDE PEROXIDE) LIQUID [RITE AID]1Current NDC, 4 package rows20240510_1262531e-0674-cf32-e063-6294a90a0d0b.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
11822-611711822-6117-0, 11822-6117-1

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB
TARTARIC ACIDW4888I119HIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM CITRATE1Q73Q2JULRIACT

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
Rite Aid Earwax Removal DropsCARBAMIDE PEROXIDERite Aid1262531e-0674-cf32-e063-6294a90a0d0b2024-05-10WarningsExact identifier
ndc (package): 11822-6117-0
ndc (package): 11822-6117-1
ndc (product): 11822-6117
ndc11 (package): 11822611701
ndc11 (package): 11822611700
spl id: 1262531e-0673-cf32-e063-6294a90a0d0b
spl set id: 1262531e-0674-cf32-e063-6294a90a0d0b

Reported adverse events (FAERS/openFDA)#

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