Label: SINUCLEAN- ecballium elaterium solution 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 October 22, 2009

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  • ACTIVE INGREDIENT

    Ecballium Elaterium extract

  • PURPOSE

    PURPOSE

    Helps expel mucus from the paranasal sinuses.

    Helps reduce symptoms of sinusitis (headache, facial pain, heavy head, nasal obstruction, malaise).

    USES

    • Reduces intensity and duration of sinusitis symptoms.
    • Helps expel mucus from the paranasal sinuses.
    • Facilitates recovery sinusitis attack.
  • WARNINGS

    WARNING

    Stop use and ask a doctor in case symptoms persist and are accompanied by fever.

    Contains no antibacterial, anti-allergic or anti-flu activity.

    If you are pregnant or breast-feeding, consult a doctor before use.

    Do not use in children under 6 years old.

    Keep out of reach of children.

    Do not use if you are allergic to one of the ingredients or the product.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    In erect position, gently insert the nozzle into each nostril, the spray 2 to 3 puffs. Repeat 2 times/day, for 3-6 days. In case of excessive sneezing after the first spray puff, repeat the treatment after 15 minutes, as the product could have been wiped away mechanically by the sneezing.,

    Do not expose the product to the light or heat. Take care to close the bottle after the use.

  • INACTIVE INGREDIENT

    Purified Water, Eucalyptol, Mint Aroma, Methylparaben, Propylparaben

  • PRINCIPAL DISPLAY PANEL

    This section contains images of the bottle and carton labels.

    This is the bottle label.

    image of bottle label

    This is the carton label.

    image of carton label


  • INGREDIENTS AND APPEARANCE
    SINUCLEAN 
    ecballium elaterium solution spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47784-001
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECBALLIUM ELATERIUM FRUIT (UNII: 8P8HWT6ZWC) (ECBALLIUM ELATERIUM FRUIT - UNII:8P8HWT6ZWC) ECBALLIUM ELATERIUM FRUIT22.09 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47784-001-011 in 1 CARTON
    112 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/22/2009
    Labeler - Galsor S.r.l (338738618)
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