SINUCLEAN- ecballium elaterium solution spray

SinuClean by

Drug Labeling and Warnings

SinuClean by is a Homeopathic medication manufactured, distributed, or labeled by Galsor S.r.l. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

This is the carton label.

INGREDIENTS AND APPEARANCE

SINUCLEAN 
ecballium elaterium solution spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 47784-001
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ECBALLIUM ELATERIUM FRUIT (UNII: 8P8HWT6ZWC) (ECBALLIUM ELATERIUM FRUIT - UNII:8P8HWT6ZWC)	ECBALLIUM ELATERIUM FRUIT	22.09 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
EUCALYPTOL (UNII: RV6J6604TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47784-001-01	1 in 1 CARTON
1		12 mL in 1 BOTTLE, SPRAY

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)