OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]

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  • OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]

OXYMETAZOLINE HCL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PERRIGO NEW YORK INC]
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NDC 45802-410-59
Set ID a1103cd8-344b-4a65-8a60-3c7be86d01a6
Category HUMAN OTC DRUG LABEL
Packager Perrigo New York Inc
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredient

    Oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    •
    temporarily relieves nasal congestion due to:
    •
    common cold
    •
    hay fever
    •
    upper respiratory allergies
    •
    temporarily relieves sinus congestion and pressure
    •
    shrinks swollen nasal membranes so you can breathe more freely
  • 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 (1-800-222-1222).

  • 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 Use: Push firmly down on cap and turn counter clockwise. To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use. Secure cap after use.

  • Other information

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

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

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Afrin® active ingredient

    Oxymetazoline HCl 0.05%

    Nasal Decongestant

    Fast, Powerful Congestion Relief

    For Colds & Allergies

    Maximum Strength

    12 Hour Relief

    Spray Mist

    1 FL OZ (30 mL)

    304RT-oxymetazoline-hcl.jpg
  • INGREDIENTS AND APPEARANCE
    OXYMETAZOLINE HCL 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-410
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (Translucent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45802-410-591 in 1 CARTON12/05/2005
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/05/2005
    Labeler - Perrigo New York Inc (078846912)
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