FDA.reportPublic FDA data

Swim-EAR

Manufacturer
Fougera Pharmaceuticals, LLC
Effective date
2026-03-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:52:23

Label at a glance#

ProductSwim-EAR
Active ingredientISOPROPYL ALCOHOL
Label structure6 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol, 95%

Purpose

OTC - PURPOSE SECTION

Ear drying aid

Uses

INDICATIONS & USAGE SECTION

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

  • swimming
  • showering
  • bathing
  • washing the hair.

Warnings

WARNINGS SECTION

Flammable: Keep away from fire or flame.

SPL UNCLASSIFIED SECTION

OTC - DO NOT USE SECTION

Do not use in the eyes.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - WHEN USING SECTION

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions
Apply 4 to 5 drops in each affected ear.

INACTIVE INGREDIENT SECTION

Inactive ingredient
Anhydrous glycerin 5% base.

SPL UNCLASSIFIED SECTION

E. FOUGERA & CO.
A division of
Fougera Pharmaceuticals Inc.
Melville, New York 11747
IP4808C
R10/12
#8

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0126-91

Swim-EAR®

EAR DRYING AID

29.57 mL (1 fl oz)

Swimear1
Swimear1

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 Oz Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0126-91

Swim-EAR®

EAR DRYING AID

29.57 mL (1 fl oz)

Swimear2
Swimear2

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130301680126913GTIN-13: 0301680126913
EAN-13: 0301680126913
GTIN-12: 301680126913
UPC-A: 301680126913
GTIN storage (14 digits): 00301680126913		swimear1.jpg, swimear2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0126-91Swim-EAR1 in 1 CARTONSOLUTION15
0168-0126-91Swim-EAR29.57 mL in 1 BOTTLE, DROPPERSOLUTION29.575

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0126-91ML - Milliliter0168-012601ba05f7-fd07-4cd7-97c5-04ba2d1887ca12013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163021
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163021
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1

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
0168-01260168-0126-91

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
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Swim-EARSWIM-EARFougera Pharmaceuticals, LLCb849acb5-e20b-464c-948b-8dcc51fdaf702026-03-26WarningsExact identifier
ndc (package): 0168-0126-91
ndc (product): 0168-0126
ndc11 (package): 00168012691
spl id: f41c4af6-33dd-48b1-bff2-a4eefad5e70a
spl set id: b849acb5-e20b-464c-948b-8dcc51fdaf70

Reported adverse events (FAERS/openFDA)#

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