LEADER Ear Drops for Swimmers

Manufacturer: Cardinal Health, 110 dba Leader | Pharma Nobis, LLC
Effective date: 2023-12-22
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:05:29

Label at a glance#

ProductLEADER Ear Drops for Swimmers

Active ingredientISOPROPYL ALCOHOL

Label structure9 sections

Contacts and useful links#

PhonePoison Help1-800-222-1222

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

ear

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
631799	isopropyl alcohol 95 % Otic Solution	PSN	5
631799	isopropyl alcohol 0.95 ML/ML Otic Solution	SCD	5
631799	isopropyl alcohol 94.998 % Otic Solution	SY	5
631799	isopropyl alcohol 95 % Otic Solution	SY	5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70000-0478-1	LEADER Ear Drops for Swimmers	30 mL in 1 CONTAINER	LIQUID	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70000-0478	LEADER EAR DROPS FOR SWIMMERS LIQUID [CARDINAL HEALTH, 110 DBA LEADER]	5	Current NDC, Legacy NDC, 1 package rows	20231223_874857eb-2a9d-6ef7-e053-2995a90af156.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0478-1	ML - Milliliter	70000-0478	83c23365-3366-4f3f-b091-b98993d934aa	1	2020-08-06

Products#

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

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

LEADER Ear Drops for Swimmers
GLYCERIN
ISOPROPYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70000-0478	70000-0478-1

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
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL ALCOHOL	ND2M416302	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEADER Ear Drops for Swimmers	LEADER EAR DROPS FOR SWIMMERS	Cardinal Health, 110 dba Leader	874857eb-2a9d-6ef7-e053-2995a90af156	2023-12-22	Warnings	Exact identifier ndc (package): 70000-0478-1 ndc (product): 70000-0478 ndc11 (package): 70000047801 spl id: 0d19b149-c1b1-5180-e063-6394a90ad905 spl set id: 874857eb-2a9d-6ef7-e053-2995a90af156

Reported adverse events (FAERS/openFDA)#

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