FDA Label for Sinuclean
View Indications, Usage & Precautions
Sinuclean Product Label
The following document was submitted to the FDA by the labeler of this product Galsor S.r.l. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Ecballium Elaterium extract
Otc - 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
Package Label.Principal Display Panel
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