FDA.reportPublic FDA data

Ear Drops for Swimmers

Manufacturer
Humco Holding Group, Inc.
Effective date
2021-12-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:45:53

Label at a glance#

ProductEar Drops for Swimmers
Active ingredientISOPROPYL ALCOHOL
Label structure17 sections

Dosage and administration

Apply 4 to 5 drops in each affected ear. Apply 4 to 5 drops in each affected ear. (12/2021)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DDM Ear Drops for Swimmers

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 95% in anhydrous glycerin

Purpose

OTC - PURPOSE SECTION

Ear drying aid

Use

INDICATIONS & USAGE SECTION

Dries water in the ears.

Warnings

WARNINGS SECTION

Flammable: Keep away from fire and flame.

Do not use

OTC - DO NOT USE SECTION

in the eyes.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Ear drainage or discharge.

Pain, irritation, or rash in the ear.

Have had ear surgery.

Dizziness.

Stop use and ask doctor if

OTC - STOP USE SECTION

Irritation (too much burning) or pain occurs.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • In case of accidental ingestion, seek professional assistant or contact a Poison Control Center immediately. 

Directions

DOSAGE & ADMINISTRATION SECTION

Apply 4 to 5 drops in each affected ear.

RECENT MAJOR CHANGES SECTION

Apply 4 to 5 drops in each affected ear. (12/2021)

Other information

OTHER SAFETY INFORMATION

Store at room temperature.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Glycerin

DDM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DDMEar.jpgDDMEar.jpg

HEB

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEBEar.jpgHEBEar.jpg

CVS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVSEar.jpgCVSEar.jpg

Leader

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LdrEar.jpgLdrEar.jpg

QC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QCEar.jpgQCEar.jpg

PV

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PVEar.jpgPVEar.jpg

RA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RAEar.jpgRAEar.jpg

Top Care

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TCEar.jpgTCEar.jpg

Equate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Equate Ear Drops LabelEquate Ear Drops LabelEquateEar.jpgEquateEar.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
631799isopropyl alcohol 95 % Otic SolutionPSN4
631799isopropyl alcohol 0.95 ML/ML Otic SolutionSCD4
631799isopropyl alcohol 94.998 % Otic SolutionSY4
631799isopropyl alcohol 95 % Otic SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0395-9103-912022-07-29C16284748780-1e4f33bdf-9e25-d8a0-e053-dadaa90a6e4ePrivate Label Ear Drops for Swimmers

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9103-91Ear Drops for Swimmers30 mL in 1 BOTTLE, PLASTICLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9103EAR DROPS FOR SWIMMERS (ISOPROPYL ALCOHOL) LIQUID [HUMCO HOLDING GROUP, INC.]4Legacy NDC, 1 package rows20211224_60403925-6ed1-77b8-e053-2991aa0ad902.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
0395-91030395-9103-91

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
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
d3d25c73-51e9-e2d1-e053-2995a90a23b260403925-6ed1-77b8-e053-2991aa0ad9022021-12-23WarningsExact identifier
spl id: d3d25c73-51e9-e2d1-e053-2995a90a23b2
spl set id: 60403925-6ed1-77b8-e053-2991aa0ad902