Active Ingredients
Kali bichromicum 6X
Luffa operculata 6X
Sabadilla 6X
Sinus Relief
FDA Label NDC 59262-243
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Similasan Corporation for the product Sinus Relief (NDC 59262-243). 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 active ingredients, purpose, uses*, warnings, keep out of reach of children., ask a doctor before use if you:, stop use and ask a doctor if:, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
sinus congestion, runny nose, sinus pressure, nasal dryness
runny nose, nasal dryness, sinus congestion
sneezing, itching
Uses*
According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• Runny nose due to colds
• Sinus pressure
• Nasal congestion
• Post-nasal drip
• Irritating dryness of nasal passages
Warnings
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
• Replace cap tightly after every use.
• To avoid contamination, do not touch the tip of the container to any surface besides nose.
• Discard open bottle after 6 months.
• The use of this container by more than one person may spread infection.
If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Ask A Doctor Before Use If You:
• Are susceptible to nose bleeds.
• Are prone to ear, nose or throat sensitivity.
Stop Use And Ask A Doctor If:
• symptoms worsen or persist for more than 72 hours
Directions
For adults and children ages 2 and over:
• Remove tamper-evident plastic seal from bottle.
• Lift cap off bottle.
• Spray 1-3 times into each nostril.
• Use as needed.
• Replace cap after use.
Other Information
Active ingredients are manufactured according to homeopathic principles.
Inactive Ingredients
Purified water, Sodium chloride
Questions?
Reach our representatives at 1-800-240-9780 or [email protected].
www.SimilasanUSA.com
*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Principal Display Panel
NDC 59262-243-20
Similasan
Sinus
Relief
20 mL/ 0.68 fl oz
Ndc 59262-243-20similasansinusrelief20 mL/ 0.68 Fl Oz (Sinus Relief 01)
* Please review the disclaimer below.
