Label: SINUS- pulsatilla, euphorbium, allium cepa, histaminum, luffa operculata, sabadilla, hepar sulfur. liquid

  • NDC Code(s): 66492-004-02
  • Packager: Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics
  • 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 December 29, 2021

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Pulsatilla 2X, Euphorbium 4X, Allium Cepa 6X, Histaminum 6X, Luffa Operculata 6X, Sabadilla 6X, Hepar Sulfur 12X

  • INDICATIONS & USAGE

    INDICATIONS: For the temporary relief of acute and chronic rhinitis, sinusitis and hayfever.

  • WARNINGS

    WARNINGS:

    If symptoms persist or worsen, a health professional should be consulted. As with any drug, if you are pregnant or nursing seek the advice of your physician before using the product.

    KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    DOSAGE: 1 spray in each nostril three to eight times daily.

  • OTHER SAFETY INFORMATION

    TAMPER EVIDENT: There is a safety seal on the neck and cap of the bottle. Do not use this product if the safety seal is broken or missing.

    Store tightly closed, protect from excessive heat, light and moisture.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Demineralized Water, Sodium Chloride, Benzalkonium Chloride.

  • QUESTIONS

    Manufactured for:

    Be Well Homeopathics Inc.

    Miami, Florida 33178

    1-877-438-3042

    www.bewellhomeo.com

  • PRINCIPAL DISPLAY PANEL

    NDC 66492-004-02

    Be Well Homeopathics™

    SINUS NASAL SPRAY

    30 ml

    1oz bottle label

    Temporary relief of acute and chronic rhinitis, sinusitis and hayfever.

  • INGREDIENTS AND APPEARANCE
    SINUS 
    pulsatilla, euphorbium, allium cepa, histaminum, luffa operculata, sabadilla, hepar sulfur. liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66492-004
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS2 [hp_X]  in 1 mL
    EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN4 [hp_X]  in 1 mL
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE6 [hp_X]  in 1 mL
    LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT6 [hp_X]  in 1 mL
    SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66492-004-0230 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2017
    Labeler - Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathics (052584997)
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