Sinuclean
FDA Label NDC 47784-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Galsor S.r.l for the product Sinuclean (NDC 47784-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

This section contains images of the bottle and carton labels.

This is the bottle label.

Image Of Bottle Label (Bottle Label)

Image Of Bottle Label (Bottle Label)

This is the carton label.

Image Of Carton Label (Carton Label)

Image Of Carton Label (Carton Label)


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