Label: LEADER ORIGINAL NASAL - oxymetazoline hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

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

  • ACTIVE INGREDIENT

    Active Ingredient                                                                   Purpose

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

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  • PURPOSE

    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
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  • WARNINGS

    Warnings

    For external use only

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  • ASK DOCTOR

    Ask a doctor before use if you have

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

    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
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  • STOP USE

    Stop use and ask a doctor if symptoms persist

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  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

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  • INDICATIONS & USAGE

    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.  Do 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.
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  • STORAGE AND HANDLING

    Other information

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

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

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  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    CIN 4584645

    www.myleader.com

    1-800-200-6313

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    LEADER ORIGINAL NASAL 
    oxymetazoline hydrocholoride spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37205-735
    Route of Administration NASAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYMETAZOLINE HYDROCHLORIDE (OXYMETAZOLINE) OXYMETAZOLINE HYDROCHLORIDE 0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE  
    EDETATE DISODIUM  
    POLYETHYLENE GLYCOL 400  
    SODIUM PHOSPHATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-735-10 1 in 1 CARTON
    1 30 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/30/2012
    Labeler - CARDINAL HEALTH (097537435)
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