SINUCLEAN - ecballium elaterium solution 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.

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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

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 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)

Revised: 10/2009
Document Id: fb1962d5-b6a6-4f41-a88d-33c891d5961b
Set id: 754e5fd3-505e-412d-917b-78f25b0c575c
Version: 1
Effective Time: 20091022
 
Galsor S.r.l