LEADER SEVERE CONGESTION NASAL

Manufacturer: CARDINAL HEALTH
Effective date: 2012-02-14
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:49:38

Label at a glance#

ProductLEADER SEVERE CONGESTION NASAL

Active ingredientOXYMETAZOLINE HYDROCHLORIDE

Label structure13 sections

Storage and handling

Other information store between 15 o to 25 o C (59 o and 77 o F) retain carton for future reference on full labeling

Contacts and useful links#

PhoneLabel contact1-800-200-6313

Websitewww.myleader.com

www.myleader.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Oxymetazoline hydrochloride 0.05% ......................................Nasal decongestant

OTC - PURPOSE SECTION

Uses

temporarily relieves nasal congestion due to
common cold
hay fever
upper respiratory allergies
sinusitis
shrinks swollen nasal membranes so you can breathe more freely

WARNINGS SECTION

Warnings

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

OTC - WHEN USING SECTION

When using this product

do not use more than directed
do not use more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen
temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
use of this container by more than one person may spread infection

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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.

INDICATIONS & USAGE SECTION

Directions

adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Don not exceed 2 doses in any 24-hour period.
children under 6 years of age : ask a doctor. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.

STORAGE AND HANDLING SECTION

Other information

store between 15^o to 25^oC (59^o and 77^oF)
retain carton for future reference on full labeling

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzalkonium chloride solution, edetate disodium, polyethylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 3467651

www.myleader.com

1-800-200-6313

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of carton labelEnter section text here

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37205-336-10	2025-04-11	C162847	48780-1	97449f38-bf1e-f6ea-e053-dbdaa90aa703	Drug Facts
37205-336-10	2019-11-13	C162847	48780-1	97449f38-bf1e-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-336-10	ML - Milliliter	37205-336	bfff400c-5c9b-437a-998b-d2ee4d737348	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	1
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

LEADER SEVERE CONGESTION NASAL
OXYMETAZOLINE HYDROCHLORIDE
OXYMETAZOLINE
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37205-336	37205-336-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OXYMETAZOLINE HYDROCHLORIDE	K89MJ0S5VY	ACTIB
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

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 2 · 101 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	OINTMENT / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRALESIONAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	GEL / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SOFT TISSUE	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
aa7c77ac-c2a5-46f8-a263-6c8d38d78409			5ae3853d-926c-45c2-893a-331f6c418945	2025-04-09	Warnings	Exact identifier spl set id: 5ae3853d-926c-45c2-893a-331f6c418945

Reported adverse events (FAERS/openFDA)#

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