ZICAM COLD REMEDY (GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT, AND SCHOENOCAULON OFFICINALE SEED) SPRAY [MATRIXX INITIATIVES, INC.]

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  • ZICAM COLD REMEDY (GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT, AND SCHOENOCAULON OFFICINALE SEED) SPRAY [MATRIXX INITIATIVES, INC.]

ZICAM COLD REMEDY (GALPHIMIA GLAUCA FLOWERING TOP, LUFFA OPERCULATA FRUIT, AND SCHOENOCAULON OFFICINALE SEED) SPRAY [MATRIXX INITIATIVES, INC.]
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NDC 62750-070-10
Set ID 6daf52c8-0d91-44d5-b9b4-d03fca16117c
Category HUMAN OTC DRUG LABEL
Packager Matrixx Initiatives, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Galphimia glauca 4x, Luffa operculata 4x, Sabadilla 4x

  • Purpose

    Reduces duration and severity of the common cold

  • Uses

    • reduces duration of the common cold
    • reduces severity of cold symptoms:
      • dry, scratchy throat
      • runny nose
      • watery eyes
      • sneezing
      • nasal congestion

    Zicam® Cold Remedy was formulated to shorten the duration of the common cold and may not be effective for flu or allergies.

  • Warnings

    • For nasal use only

    Do not use if you have a sensitivity or allergy to any of the ingredients. If an allergic reaction occurs, stop use and seek medical help right away.

    Ask a doctor before use if you have

    • ear, nose, or throat sensitivity
    • susceptibility to nosebleeds

    When using this product

    • avoid contact with eyes. Rinse right away with water if it gets in eyes and seek medical help right away.
    • the use of this container by more than one person may spread infection
    • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur

    Stop use and ask a doctor if

    • symptoms get worse or last more than 7 days or are accompanied by fever
    • redness or swelling is present
    • new symptoms occur

    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

    • for best results, use at the first sign of a cold and continue to use until symptoms completely subside
    • adults and children 12 years of age and older:
      • remove cap and safety clip
      • hold with thumb at bottom of bottle and nozzle between your fingers
      • before using the first time, prime pump by depressing several times
      • place tip of nozzle just past nasal opening (approximately 1/8")
      • lean your head backwards slightly
      • pump 2 times into each nostril
      • avoid inhaling deeply
      • wipe away any excess
      • dose every 3 hours, not to exceed 5 doses in one 24 hour period
    • children under 12 years of age: do not use
  • Other information

    • store at room temperature 15-29°C (59-84°F)
  • Inactive ingredients

    benzalkonium chloride, dibasic sodium phosphate, eucalyptol, eugenol, glycine, hypromellose, menthol, monobasic sodium phosphate, phenethyl alcohol, polysorbate 80, purified water, saccharin sodium, sodium chloride, succinic acid

  • 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 62750-070-10

    ZICAM®
    COLD REMEDY

    SHORTENS COLDS

    PLUS MULTI-SYMPTOM RELIEF

    GET BETTER
    FASTER

    TAKE AT THE FIRST

    THE
    PRE-COLD®
    MEDICINE

    SIGN OF A COLD

    THE
    ONLY
    CLINICALLY
    PROVEN
    COLD SHORTENING
    NASAL SPRAY

    SEE
    WHAT'S
    INSIDE!

    No Drip
    NASAL SPRAY

    With Cooling Menthol
    & Eucalyptus

    0.50 FL OZ (15 mL)

    ZINC-FREE
    HOMEOPATHIC

    Principal Display Panel - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZICAM COLD REMEDY 
    galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-070
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP4 [hp_X]  in 0.56 mL
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT4 [hp_X]  in 0.56 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED4 [hp_X]  in 0.56 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    EUGENOL (UNII: 3T8H1794QW)  
    GLYCINE (UNII: TE7660XO1C)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SUCCINIC ACID (UNII: AB6MNQ6J6L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62750-070-101 in 1 CARTON08/01/2014
    115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC08/01/2014
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, Inc071609663MANUFACTURE(62750-070)
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