Label: LEADER NASAL DECONGESTANT- oxymetazoline hydrochloride spray

  • NDC Code(s): 70000-0665-1
  • Packager: Cardinal Health 110,Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 3, 2024

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

  • Drug Facts 

  • Active Ingredient

    Oxymetazoline 0.05%

  • Purpose

    Nasal Decongestant 

  • Uses

    Temporarily relieves nasal congestion due to:

    • common cold
    • hay fever
    • upper respiroty allergies
    • temporarily relieves sinus congestion and pressure
    • Shrinks swollen membranes so you can breathe more freely
  • Warnings

    Ask a Doctor before use if you have

    • heart diease
    • high blood pressure
    • diabetes
    • thyiod diease
    • trouble urinating due to enlarged rostate 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

  • Keep out of the reach of children

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

  • Directions

    • Before using for the first time, remove the protective cap form the tip and prime the pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostrile. Fully depress rim with a firm and even stroke, and sniff deeply.
    • Wipe nozzle clean after use.
    • 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.
  • Other information 

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

    Benzalkonium Chloride, Disodium EDTA, Glycerin, Microcrystalline Cellulose and Carboxymethylcellulose Sodium, Polyethylene Glycol 300, Povidone, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic

  • Principal Display panel 1 FLOZ 

    Leader          NDC 70000-0665-1

    12 Hour ND Nasal Decongstant

    Oxymetazoline HCL 0.05% 

    Nasal Decongestant 

    1 FLOZ (30ml)

    Sheffield_50900_LDRAllergyReliefOxymetazoline_1ozCarton REV.jpg

    Sheffield_70900_LDRAllergyReliefOxymetazoline_1ozLabel REV.jpg

  • INGREDIENTS AND APPEARANCE
    LEADER NASAL DECONGESTANT 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0665
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0665-11 in 1 CARTON03/31/2024
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/31/2024
    Labeler - Cardinal Health 110,Inc (063997360)