Dermveda Sinaflux Ultra Natural Sinus Relief Spray
FDA Label NDC 83819-608
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Celcius Corp. for the product Dermveda Sinaflux Ultra Natural Sinus Relief (NDC 83819-608). 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 drug facts, active ingredient, purpose, uses, directions, warnings, otc - keep out of reach of children, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Melaleuca alternifolia 8x HPUS
Glycyrrhiza Glabra 10X HPUS
Purpose
Anti-Microbial
Anti-Inflammatory
Uses
• temporarily relieves nasal congestion due to a cold, or other upper respiratory allergies • temporarily relieves sinus congestion, breathing and pressure.
Helps clear nasal passages :
shrinks swollen membranes
Directions
Remove the cap, With your head held upright insert nozzle into each of the nostril and push down the nozzle 2-3 times.
Warnings
The use of this dispenser by more than one person may spread infection
• Avoid spraying in eyes
• Do not exceed recommended dosage
• If pregnant or breast feeding, ask a health professional before use
Do not use • on children under 2 years of age unless directed by a doctor • Avoid contact with eyes.
When using this product
• Mild increase in irritation or burning may occur.
Stop use and ask a doctor if
• Symptoms persist or inflammation increases after weeks of use or if the itch increases.
• Increase in redness on skin.
Pregnant or Breast Feeding
• Ask a Health Professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a poison Control Center right away.
Dosage And Administration
Do Not use on Children less than 2 Years
Adults and children 4 years to under 12 years of age (with adult supervision): Apply up to 4-5 times daily to obtain the desired results. Children under 4 years check with your doctor.
Other Information
Store in a cool dry place.
Inactive Ingredients
Vegetable Glycerin, Chamomile, Quillaja extract, Water
Questions?
+1-734-726-0148
You may also report serious side effects to this phone number.
Mon-Fri 9:00 AM - 5:00 PM
Packaging
Ultra Natural Sinus Relief (83819608 2)
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