Label: SINUS RELIEF- potassium dichromate, 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 April 4, 2017

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  • SPL UNCLASSIFIED SECTION

    SINUS RELIEF

    Drug Facts

  • Active ingredients

    Kali bichromicum 6X

    Luffa operculata 6X

    Sabadilla 6X

  • Purpose

    sinus congestion, runny nose, sinus pressure, nasal dryness

    runny nose, nasal dryness, sinus congestion

    sneezing, itching

  • Uses*

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

    • Runny nose due to colds

    • Sinus pressure

    • Nasal congestion

    • Post-nasal drip

    • Irritating dryness of nasal passages

  • 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

    *These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-243-20
    Similasan
    Sinus
    Relief
    20 mL/ 0.68 fl oz

    NDC 59262-243-20 Similasan Sinus Relief 20 mL/ 0.68 fl oz

  • INGREDIENTS AND APPEARANCE
    SINUS RELIEF 
    potassium dichromate, luffa operculata fruit and schoenocaulon officinale seed spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-243
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE6 [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:59262-243-2020 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC05/01/2017
    Labeler - Similasan Corporation (111566530)
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