Label: OXYMETAZOLINE HYDROCHLORIDE spray, metered

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

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 December 30, 2009

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Oxymetazoline Hydrochloride 0.05%

  • Purpose

    Nasal Decongestant

  • Uses

    Temporarily relieves nasal congestion due to:

    • common cold
    • hay fever
    • upper respiratory allergies
    • helps clear nasal passages
    • shrinks swollen membranes
    • temporarily relieves sinus congestion and pressure
  • Warnings

    For nasal use only.

    Ask a doctor before use if you have

    • heart disease
    • 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.
      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 result
    • 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.

  • Directions

    • adults and children 6-12 years of age (with adult supervision): Pump 2 or 3 times in each nostril without tilting your head. Sniff deeply. Wipe nozzle clean after use.
    • Do not use more often than once every 10 to 12 hours.
    • Do not exceed 2 doses in any 24 hour period.
    • Children under 6 years of age: consult a doctor

    To use pump:

    • Remove cap and safety clip.
    • Hold with thumb at bottom of bottle and nozzle between fingers.
    • Before using the first time, prime pump by depressing several times.
  • Other Information

    • Retain carton for future reference on full labeling
    • Remove lock ring before each use
  • Inactive Ingredients

    aloe barbadensis gel, d-alpha-tocopherol-ester, disodium EDTA, disodium phosphate, ethylene & propylene oxide copolymer, eucalyptol, hydroxyethylcellulose, hydroxylated lecithin, menthol, monosodium phosphate, potassium sorbate, purified water

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    CVS Pharmacy, Inc.
    One CVS Drive
    Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 15 mL Carton

    CVS®
    pharmacy

    Compare to the active
    ingredient in Zicam®*

    NEW!

    Maximum
    SINUS RELIEF
    NO DRIP NASAL GEL
    OXYMETAZOLINE HCl 0.05%

    Quickly relieves sinus
    pressure & nasal congestion

    • Long-lasting
    • Non-drowsy

    12
    Hour
    Relief

    Menthol Eucalyptus

    0.5 FL OZ (15mL)

    Principal Display Panel - 15 mL Carton
  • INGREDIENTS AND APPEARANCE
    OXYMETAZOLINE HYDROCHLORIDE 
    oxymetazoline hydrochloride spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64762-864
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline Hydrochloride0.2 mg  in 0.4 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64762-864-151 in 1 CARTON
    115 mL in 1 BOTTLE, PUMP
    2NDC:64762-864-221 in 1 CARTON
    222 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/04/2009
    Labeler - Dynamic Pharmaceuticals (617660712)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dynamic Pharmaceuticals617660712MANUFACTURE
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