SinuClean: Homeopathic Product Information

SINUCLEAN — ecballium elaterium fruit spray
Galsor S.r.l

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.

Ecballium Elaterium extract

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.

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.

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.

Purified Water, Eucalyptol, Mint Aroma, Methylparaben, Propylparaben

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This is the bottle label.

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This is the carton label.

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SINUCLEAN
ecballium elaterium solution spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:47784-001
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ECBALLIUM ELATERIUM FRUIT (ECBALLIUM ELATERIUM FRUIT) ECBALLIUM ELATERIUM FRUIT 22.09 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
EUCALYPTOL
METHYLPARABEN
PROPYLPARABEN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47784-001-01 1 BOTTLE, SPRAY (BOTTLE) in 1 CARTON contains a BOTTLE, SPRAY
1 12 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (47784-001-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/22/2009
Labeler — Galsor S.r.l (338738618)

Revised: 10/2009 Galsor S.r.l

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