FDA Label for Sinucleanse Neti-pot
View Indications, Usage & Precautions
Sinucleanse Neti-pot Product Label
The following document was submitted to the FDA by the labeler of this product Ascent Consumer Products, Inc.. 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 - Purpose
Purpose
Nasal Wash
Indications & Usage
Uses
Temporarily relieves symptoms associated with
sinusitis, cold, flu or allergies
-Sneezing
-Nasal Stuffiness
-Runny nose
-Post nasal drip
Removes inhaled irritants (dust, pollen)
Removes nasal and sinus drainage
Helps reduce swelling of nasal membranes
Moisturizes dry nasal passages
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Warnings
Warnings
Stop use and ask a doctor if washing is uncomfortable
or symptoms are not relieved.
Do not use unfiltered tap water. see instructions inside box for proper water sources
Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears.
Dosage & Administration
Directions
Adults and children 4 years and over: Use 1-2 packets per 8 fl oz (240 mL) up to every 2 hours as needed.
Children under 4 years: Consult a physician
See enclosed instruction sheet for complete directions and proper use.
Other Safety Information
Other Information
-Inspect saline packets for integrity
-Do not use saline packets if open or torn
-Protect saline packets from excessive heat and moisture
-See saline packets or box for lot number and expiration date
Questions?
1-888-547-5492
Otc - Active Ingredient
Active ingredients
(in each packet)
Sodium Bicarbonate USP (700 mg)
Sodium Chloride USP (2300 mg)
Inactive Ingredient
Inactive Ingredients
None
Instructions For Use
Instructions for Use of the SinuCleanse Neti Pot
Directions: Read through entire section before using for the first time.
1. Empty the contents of one SinuCleanse Saline Wash packet into the
SinuCleanse Neti Pot. First-time users should start with 1/2 packet of
the SinuCleanse dry ingredients. As you become more accustomed to
the system, work up to using 1 full packet. Additional packets may be
purchased from your nearest pharmacy.
2. Fill the pot halfway or to the middle of the indentation with a proper water source.*
This makes 1/2 cup (4 oz. ) solution.
3. Stir thoroughly until dry ingredients have completely dissolved.
4. Proper head position allows solution to flow through the nose by gravity.
- Lean over the sink with your head bent down so you are looking directly into the basin.
Holding the pot in your right hand, gently insert the spout into your right nostril so that it
forms a comfortable seal.
- Rotate your head so that the right nostril is directly above the left. The forehead should
remain higher than the chin. Raise the handle of the pot so that the solution enters the right
nostril. In a few moments, the solution will begn to drain out the left nostril into the sink.
Do not inhale or "snort" solution into the nose - breathe through your mouth.
5. When the pot i empty, exhale through both nostrils to clear them
of excess mucus and solution. Gently blow your nose into a tissue.
6. Repeat the procedure on the other side.
7. Thoroughly rinse the pot after each use with water that has
been distilled, sterilized, filtered or previously boiled and leave the
pot to air dry completely. The SinuCleanse Neti Pot is top-rack dishwasher safe.
Package Label.Principal Display Panel
* Please review the disclaimer below.