Label: OXYMETAZOLINE HCL- oxymetazoline hydrochloride spray 

  • Label RSS
  • 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 02/12

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

  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

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  • Purpose

    Nasal decongestant

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  • Uses

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

    Ask a doctor before use if you have

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

    When using this product

    • do not use more than directed
    • do not use for 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

    Stop use and ask a doctor if

    symptoms persist

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

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  • Directions

    • adults and children 6 to under 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, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

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  • Other information

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

    benzalkonium chloride solution, benzyl alcohol, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

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  • Questions?

    1-800-719-9260

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  • Principal Display Panel

    Compare to Afrin® active ingredient

    Oxymetazoline HCl 0.05%

    Nasal Decongestant

    Fast, Powerful Congestion Relief

    12 Hour Relief

    Spray Mist

    Oxymetazoline HCl 0.05% Carton Image 1

    Oxymetazoline HCl 0.05% Carton Image 1

    Oxymetazoline HCl 0.05% Carton Image 2

    Oxymetazoline HCl 0.05% Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    OXYMETAZOLINE HCL 
    oxymetazoline hydrochloride spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45802-410
    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  
    BENZYL ALCOHOL  
    EDETATE DISODIUM  
    POLYETHYLENE GLYCOLS  
    POVIDONE  
    PROPYLENE GLYCOL  
    WATER  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE  
    Product Characteristics
    Color WHITE (Translucent) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45802-410-59 1 in 1 CARTON
    1 30 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/05/2005
    Labeler - Perrigo New York Inc (078846912)
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