Label: ZICAM COLD REMEDY- galphimia glauca flowering top, luffa operculata fruit, and schoenocaulon officinale seed spray

  • NDC Code(s): 10237-474-15
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 10, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

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

  • Purpose

    Reduces duration of the common cold and helps relieve nasal congestion

  • Uses

    Reduces duration of the common cold and helps relieve nasal congestion

    ---------------------------------------------------------------------------------------------------

    Zicam ® Cold Remedy was not formulated to 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?

    call 877-942-2626 toll free

    www.zicam.com

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    ZICAM ®

    COLD REMEDY

    SHORTENS COLDS

    TAKE AT THE FIRST

    THE
    PRE-COLD ®
    MEDICINE

    SIGN OF A COLD

    THE

    ONLY

    COLD SHORTENING

    NASAL SPRAY

    No Drip
    NASAL SPRAY

    With Cooling Menthol
    & Eucalyptus

    0.50 FL OZ (15 mL)

    ZINC-FREE
    HOMEOPATHIC

    Zicam Cold Remedy No Drip Nasal Spray.jpg

  • 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:10237-474
    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:10237-474-151 in 1 CARTON04/10/2022
    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 homeopathic04/10/2022
    Labeler - Church & Dwight Co., Inc. (001211952)
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