Label: KIDS NASAL ALLERGY RELIEF- cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit and schoenocaulon officinale seed spray

  • 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 February 8, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Cardiospermum 6X

    Galphimia glauca 6X

    Luffa operculata 6X

    Sabadilla 6X

  • Purpose

    itching, runny nose

    runny nose, watery eyes, sneezing

    runny nose, sinus congestion

    sneezing, itching

  • Uses*

    According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:

    • allergies accompanied by runny nose, itching and/or burning of the nose, watery eyes, sneezing and swollen mucous membranes (congestion)

    • post nasal drip caused by allergies

    • sinus pressure caused by allergies

  • Warnings

    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

    • Replace cap tightly after every use.

    • To avoid contamination, do not touch the tip of the container to any surface besides nose.

    • Discard open bottle after 6 months.

    • The use of this container by more than one person may spread infection.

    If pregnant, trying to get 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.

    Ask a doctor before use if you:

    • are susceptible to nose bleeds

    • are prone to ear, nose or throat sensitivity

    Stop use and ask a doctor if:

    • symptoms worsen or persist for more than 72 hours

  • Directions

    For adults and children ages 2 and over:

    • Remove tamper-evident plastic seal from bottle

    • Lift cap off bottle

    • Spray 1-3 times into each nostril

    • Use as needed

    • Replace cap after use

  • Other information

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive Ingredients

    Purified water, Sodium chloride

  • Questions?

    Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

    www.SimilasanUSA.com

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-245-20
    Kids Nasal
    Allergy
    Relief
    20 ml/ 0.68 fl oz

    PRINCIPAL DISPLAY PANEL
NDC 59262-245-20
Kids Nasal
Allergy
Relief
20 ml/ 0.68 fl oz
 PRINCIPAL DISPLAY PANEL
NDC 59262-245-20
Kids Nasal
Allergy
Relief
20 ml/ 0.68 fl oz

  • INGREDIENTS AND APPEARANCE
    KIDS NASAL ALLERGY RELIEF 
    cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit and schoenocaulon officinale seed spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-245
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) (CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR) CARDIOSPERMUM HALICACABUM FLOWERING TOP6 [hp_X]  in 20 mL
    GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E) GALPHIMIA GLAUCA FLOWERING TOP6 [hp_X]  in 20 mL
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT6 [hp_X]  in 20 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED6 [hp_X]  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-245-201 in 1 CARTON02/15/2019
    120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC02/15/2019
    Labeler - Similasan Corporation (111566530)