Label: LEADER NASAL DECONGESTANT- oxymetazoline hydrochloride spray

  • NDC Code(s): 70000-0676-1
  • Packager: Cardinal Health 110,Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 31, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient 

    Oxymetazoline HCL 0.05%

  • Purpose

    Nasal Decongestant 

  • Uses 

    Temporarily relieves nasal congestion due to:

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

  • Ask a Doctor before use if you have

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

    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

    Symptoms persist 

  • PREGNANCY OR BREAST FEEDING

    ask a health professional before use.

  • Keep out of the reach of children

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

  • Directions 

    • 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 

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

  • Inactive Ingredients 

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

  • 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_Carton

    Leader_Nasal_0.5_Labels

  • INGREDIENTS AND APPEARANCE
    LEADER NASAL DECONGESTANT 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0676
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POVIDONE (UNII: FZ989GH94E)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0676-11 in 1 CARTON05/30/2024
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/30/2024
    Labeler - Cardinal Health 110,Inc (063997360)