FDA.reportPublic FDA data

Rite Aid Ear Drops for Swimmers

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 DRYING AGENT
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 95% in 5% Anhydrous Glycerin

OTC - PURPOSE SECTION

Ear Drying Aid

INDICATIONS & USAGE SECTION

Dries water in the ears

WARNINGS SECTION

Flammable: Keep away from fire or flame

Do not use in the eyes

DOSAGE & ADMINISTRATION SECTION

Apply 4 to 5 drops in each affected ear

OTC - WHEN USING SECTION

Store at room temperature

keep tightly closed

INACTIVE INGREDIENT SECTION

Glycerin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. in case of accidental ingestion, seek professional assitance or contact a poison control center immediately. (1-800-222-1222)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rite Aid Swimmers Ear Label 12-30-22Rite Aid Swimmers Ear Label 12-30-22Rite Aid Swimmers Ear Carton 12-30-22Rite Aid Swimmers Ear Carton 12-30-22rite aid swimmersrite aid swimmers

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN5
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD5
631799isopropyl alcohol 94.998 % Otic SolutionSY5
631799isopropyl alcohol 95 % Otic SolutionSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11822-1233-12020-02-04C16284748780-19d75b9d0-7ed0-f424-e053-dadaa90a57ceRite Aid Ear Drops for Swimmers
11822-1233-12020-01-31C16284748780-19d75b9d0-7ed0-f424-e053-dadaa90a57ceRite Aid Ear Drops for Swimmers

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-1233-1EAR DRYING AGENT30 mL in 1 BOTTLELIQUID305
11822-1233-1EAR DRYING AGENT1 in 1 CARTONLIQUID15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-1233EAR DRYING AGENT (ISOPROPYL ALCOHOL 94.998% GLYCERIN 5%) LIQUID [RITE AID]5Current NDC, Legacy NDC, 2 package rows20231216_9b4299af-c1a2-43e6-90d4-25f4c89d1bef.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-123311822-1233-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
EAR DRYING AGENTISOPROPYL ALCOHOL 94.998% GLYCERIN 5%Rite Aid9b4299af-c1a2-43e6-90d4-25f4c89d1bef2023-12-15WarningsExact identifier
ndc (package): 11822-1233-1
ndc (product): 11822-1233
ndc11 (package): 11822123301
spl id: 0c93a4bc-8f42-0307-e063-6294a90acea4
spl set id: 9b4299af-c1a2-43e6-90d4-25f4c89d1bef

Reported adverse events (FAERS/openFDA)#

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