Label: OXYMETAZOLINE HCL spray

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 February 13, 2015

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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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