OXYMETAZOLINE HCL SPRAY [PURINEPHARMA LLC]

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OXYMETAZOLINE HCL SPRAY [PURINEPHARMA LLC]
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NDC 58599-027-01, 58599-027-17
Set ID bde446d1-f867-41c1-9bfa-79bb8ff65f24
Category HUMAN OTC DRUG LABEL
Packager PURINEPHARMA LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • ACTIVE INGREDIENT

    Active Ingredient: Oxymetazoline HCl 0.05%

  • PURPOSE

    Purpose: Nasal Decongestant

  • INDICATIONS & USAGE

    Uses
    Temporarily relieves nasal congestion due to:

    • common cold
    • hay fever
    • upper respiratory allergies
    • sinusitis
    • shrinks swollen nasal membrances so you can breathe more freely.
  • WARNINGS

    Ask a doctor before use if you have

    • high blood pressure
    • thyroid disease
    • diabetes
    • 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.

  • WHEN USING

    When using this product

    • Frequent or prolonged use may cause nasal congestion to rcur or worsen
    • temporary discomfort such as buming, stinging, sneezing or an increase in nasal discharge may occur
    • use of this container by more than one person may spread infection
  • PREGNANCY OR BREAST FEEDING

    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

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

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostrill not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
    Children under six 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.

  • STORAGE AND HANDLING

    Store between 20°C to 25°C (68° to 77° F)

    Retain carton for future reference on full labeling.

  • INACTIVE INGREDIENT

    Purified Water, Edetate Disodium, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Povidone, Benzalkonium Chloride Solution, Polyethylene Glycol, Propylene Glycol

  • HOW SUPPLIED

    NDC 58599-027-01: 30 mL in a Bottle, NDC 58599-027-17: 15 mL in a Bottle

  • PRINCIPAL DISPLAY PANEL

    Nasal Spray
    Label Text
    Carton
  • INGREDIENTS AND APPEARANCE
    OXYMETAZOLINE HCL 
    oxymetazoline hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-027
    Route of AdministrationORAL, Type 0: Not a Combination Product
    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
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58599-027-011 in 1 CARTON
    130 mL in 1 BOTTLE
    2NDC:58599-027-171 in 1 CARTON
    215 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/09/2015
    Labeler - PURINEPHARMA LLC (019950491)
    Registrant - PURINEPHARMA LLC (019950491)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURINEPHARMA LLC019950491manufacture(58599-027)
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