ZICAM ALLERGY RELIEF (GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, AND SULFUR) GEL [MATRIXX INITIATIVES, INC.]

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  • ZICAM ALLERGY RELIEF (GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, AND SULFUR) GEL [MATRIXX INITIATIVES, INC.]

ZICAM ALLERGY RELIEF (GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, AND SULFUR) GEL [MATRIXX INITIATIVES, INC.]
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NDC 62750-004-15
Set ID c55e0ea1-bb67-4595-8938-d62b144efa59
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 12x, 30x
    Histaminum hydrochloricum 12x, 30x, 200x
    Luffa operculata 4x, 12x, 30x
    Sulphur 12x, 30x, 200x

  • Purpose

    Upper respiratory allergy symptom relief

  • Uses

    • temporarily relieves symptoms due to hay fever or other upper respiratory allergies such as:
      • sinus pressure
      • itchy, runny nose
      • sneezing
      • itchy, watery eyes
      • nasal congestion
  • Warnings

    For nasal use only.

    Ask a doctor before use if you have

    • ear, nose, or throat sensitivity
    • susceptibility to nosebleeds
    • breathing problem such as emphysema or chronic bronchitis

    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 individual swabs 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 persist or are accompanied by fever

    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 12 years of age and older:
      • open tube (also see illustrations on side of carton):
        • hold tube between thumb and forefinger at the blue band
        • with the other hand hold at base of handle and snap open tube
        • pull out swab
      • apply medication just inside first nostril. Remove swab and press lightly on the outside of first nostril for about 5 seconds. Re-dip swab in tube. Apply medication to second nostril. Remove swab and press lightly on the outside of the second nostril for about 5 seconds. Do not insert swab more than 1/4″ past nasal opening.
      • discard swab after use
      • wait at least 30 seconds before blowing nose
      • use 1 tube every 4 hours
    • optimal results may not be seen for 1-2 weeks. After 1-2 weeks, you may need to use only 1-2 times daily. For best results, use up to 1 week before contact with known causes of your allergies.
    • children under 12 years of age: ask a doctor
  • Other information

    • store between 15-29°C (59-84°F)
  • Inactive ingredients

    benzalkonium chloride, benzyl alcohol, edetate disodium, glycerin, hydroxyethylcellulose, menthol, potassium chloride, potassium phosphate, purified water, sodium chloride, sodium phosphate

  • Questions? Comments? Side Effects?

    call 877-942-2626 toll free
    www.zicam.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 15 Swab Tube Carton

    NDC 62750-004-15

    ZICAM®

    GENTLE
    ALLERGY
    RELIEF

    THE ONLY
    ALLERGY RELIEF
    NASAL SWAB

    NASAL SWABS
    with Cooling Menthol

    Effective Non-Drowsy Relief of:

    • Nasal Congestion    • Itchy Eyes
    • Itchy, Runny Nose   • Sneezing

    No Known Allergy Drug Interactions

    15 MEDICATED SWABS
    HOMEOPATHIC

    PRINCIPAL DISPLAY PANEL - 15 Swab Tube Carton
  • INGREDIENTS AND APPEARANCE
    ZICAM ALLERGY RELIEF 
    galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, and sulfur gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62750-004
    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 TOP30 [hp_X]  in 1.1 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE200 [hp_X]  in 1.1 mL
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT30 [hp_X]  in 1.1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR200 [hp_X]  in 1.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62750-004-1515 in 1 CARTON02/15/2015
    11.1 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/15/2015
    Labeler - Matrixx Initiatives, Inc. (790037253)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unicep790263909MANUFACTURE(62750-004)
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