ZICAM (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MATRIXX INITIATIVES, INC.]

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ZICAM (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [MATRIXX INITIATIVES, INC.]
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NDC 62750-006-10
Set ID 954d98e4-af3e-49d6-a1ba-35ef9446d8a8
Category HUMAN OTC DRUG LABEL
Packager Matrixx Initiatives, Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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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:
      • the common cold
      • hay fever
      • upper respiratory allergies
    • temporarily relieves sinus congestion and pressure
    • helps clear nasal passages
    • shrinks swollen membranes
  • Warnings

    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 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 pump:

    • to open, hold the actuator to squeeze and turn cap
    • hold with thumb at bottom of bottle and nozzle between fingers
    • before using the first time, prime pump by depressing several times
    • place tip of nozzle just past nasal opening (approximately 1/8")
    • pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
    • wipe nozzle clean after use
    • to close, turn cap until it 'clicks'
  • Other information

    • store between 15-29°C (59-84°F)
    • retain carton for future reference on full labeling
  • Inactive ingredients

    aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, dl-alpha tocopherol, eucalyptol, glycerin, hydroxyethylcellulose, hydroxylated lecithin, menthol, monosodium phosphate, polysorbate 80, purified water

  • Questions? Comments? Side Effects?

    call 877-942-2626 toll free

  • SPL UNCLASSIFIED SECTION

    Distributed by Matrixx Initiatives, Inc.
    Scottsdale, Arizona 85260.

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    NDC 62750-006-10

    ZICAM®

    INTENSE
    SINUS
    RELIEF

    NASAL DECONGESTANT
    OXYMETAZOLINE HCl

    12
    HOUR
    RELIEF

    COLDS*ALLERGIES

    Maximum Strength
    Relief of Painful
    Sinus Pressure

    No-Drip Liquid®
    NASAL SPRAY

    Cooling
    Menthol & Eucalyptus

    0.50 FL OZ (15 mL)

    Principal Display Panel - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZICAM 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-006
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    oxymetazoline hydrochloride (UNII: K89MJ0S5VY) (oxymetazoline - UNII:8VLN5B44ZY) oxymetazoline hydrochloride.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    benzyl alcohol (UNII: LKG8494WBH)  
    edetate disodium (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    eucalyptol (UNII: RV6J6604TK)  
    glycerin (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62750-006-101 in 1 CARTON05/29/2002
    115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/29/2002
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, Inc.071609663MANUFACTURE(62750-006)
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