FDA.reportPublic FDA data

Topcare Swimmers Ear Drops

Manufacturer
Topco Associates LLC | Derma Care Research Labs LLC
Effective date
2024-01-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:57

Label at a glance#

ProductTopcare Swimmers Ear Drops
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 95%

OTC - PURPOSE SECTION

Ear drying aid.

INDICATIONS & USAGE SECTION

Dries water in the ears and relieves water-clogged ears after

  • swimming
  • showering
  • bathing
  • washing the hair

WARNINGS SECTION

Flammable: Keep away from fire or flame.

Do not use in eyes.

Ask a doctor before use if you have

  • ear drainage or discharge
  • pain, irritation or rash in ear
  • had ear surgery
  • dizziness

Stop us and ask a doctor if irritation (too much burning) or pain occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center fight away.

DOSAGE & ADMINISTRATION SECTION

Apply 4 to 5 drops in each affected ear.

INACTIVE INGREDIENT SECTION

Anhydrous glycerin 5% base

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN1
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD1
631799isopropyl alcohol 94.998 % Otic SolutionSY1
631799isopropyl alcohol 95 % Otic SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-107-01Topcare Swimmers Ear Drops1 in 1 BOXLIQUID11
76162-107-01Topcare Swimmers Ear Drops28 g in 1 BOTTLELIQUID281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-107TOPCARE SWIMMERS EAR DROPS (ISOPROPYL ALCOHOL) LIQUID [TOPCO ASSOCIATES LLC]1Current NDC, 2 package rows20240127_0fddeb43-fee0-d43c-e063-6394a90a738a.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-10776162-107-01

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
Topcare Swimmers Ear DropsISOPROPYL ALCOHOLTopco Associates LLC0fddeb43-fee0-d43c-e063-6394a90a738a2024-01-26WarningsExact identifier
ndc (package): 76162-107-01
ndc (product): 76162-107
ndc11 (package): 76162010701
spl id: 0fddeb43-fee1-d43c-e063-6394a90a738a
spl set id: 0fddeb43-fee0-d43c-e063-6394a90a738a

Reported adverse events (FAERS/openFDA)#

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