LEADER Nasal Decongestant Spray Oxymetazoline

Manufacturer
Cardinal Health 110,Inc
Effective date
2024-05-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:13:13

Label at a glance#

ProductLeader Nasal Decongestant
Active ingredientOXYMETAZOLINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

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

Dosage and administration

Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. Children under 6 years of age consult a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.

Label contents#

Full prescribing information#

Active ingredient 

OTC - ACTIVE INGREDIENT SECTION

Oxymetazoline HCL 0.05%

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant 

Uses 

INDICATIONS & USAGE SECTION

Temporarily relieves nasal congestion due to:

  • common cold
  • hay fever
  • sinusitis
  • upper respiratory allergies
  • shrinks swollen membranes so you can breathe more freely

Ask a Doctor before use if you have

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

Do not use more than directed

  • do not use for more than three 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Symptoms persist 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center right away.

Directions 

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 6 to under 12 years of age (with adult supervision):2 or 3 sprays in each nostril not more than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
  • Children under 6 years of age consult a doctor.To spray, squeeze bottle quickly and firmly. Do not tilt head backwards while spraying, wipe nozzle clean after use.

Other information 

OTHER SAFETY INFORMATION

store between 20° and 25°C (68° to 77°F)
retain carton for future reference on full labeling

Inactive Ingredients 

INACTIVE INGREDIENT SECTION

benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader  Original Nasal Spray NDC 70000-0676-1
Oxymetazoline Hydrochloride 0.05%
12 hour Nasal Mist Nasal Decongestant
1/2 FLOZ (15ML)

Leader_Nasal_0.5_CartonLeader_Nasal_0.5_Carton

Leader_Nasal_0.5_LabelsLeader_Nasal_0.5_Labels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN2
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD2
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OXYMETAZOLINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0676-1Leader Nasal Decongestant1 in 1 CARTONSPRAY12
70000-0676-1Leader Nasal Decongestant15 mL in 1 BOTTLESPRAY152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0676LEADER NASAL DECONGESTANT (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [CARDINAL HEALTH 110,INC]2Current NDC, 2 package rows20240601_6594c117-6ffc-4bda-8bbf-e91c810f2c3f.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-067670000-0676-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
Leader Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDECardinal Health 110,Inc6594c117-6ffc-4bda-8bbf-e91c810f2c3f2024-05-31WarningsExact identifier
ndc (package): 70000-0676-1
ndc (product): 70000-0676
ndc11 (package): 70000067601
spl id: ff4f84df-c42c-4d9d-8f51-8c97a0939f09
spl set id: 6594c117-6ffc-4bda-8bbf-e91c810f2c3f

Reported adverse events (FAERS/openFDA)#

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