FDA Label for Sinucleanse Squeeze
View Indications, Usage & Precautions
Sinucleanse Squeeze 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 form 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 Squeeze
Directions: Read through entire section before using for the first time.
1. Remove the cap from the SinuCleanse Squeeze bottle.
2. Pour the pre-mixed saline dry ingredients into the SinuCleanse Squeeze
Bottle. First-time users should start with 1 packet of the saline dry
ingredients. As you become more accustomed to the system, work up
to using 2 full packets. Additional packets may be purchased from your
nearest pharmacy.
3. Fill the bottle with a proper water source * leaving approximately 1/2 inch
of air at the top of the bottle. This makes 1 cup ( 8 oz. ) of solution.
4. Tighten the cap on the bottle securely, place one finger over the tip of the cap and gently
shake the bottle until the dry ingredients have completely dissolved.
5. Lean over the sink with your head bent down so you are looking directly into the basin. Place
the tip of the cap up to the right nostril and gently insert the tip so that it forms a comfortable
seal. Aim the tip at the back of your head, not at the top of your head.
6. Squeeze the bottle gently so that the solution enters the right nostril. Do not inhale or "snort"
the solution into the nose - breathe through your mouth.
7. In a few moments the solution will begin to drain out of the left nostril. Continue to squeeze
the bottle gently until you have used approximately half of the solution.
8. Remove the tip of the bottle from your nostril, then exhale through both nostrils
to clear them of excess mucus and solution. Gently blow your nose into a tissue.
9. Repeat the procedure on the left nostril with the remaining solution.
10. A small amount of solution will remain at the bottom of the bottle. Discard the
remaining solution.
11. Thoroughly rinse the bottle after each use with water that has been distilled,
sterilized, filtered or previously boiled and leave the bottle open to air dry
completely. The SinuCleanse Squeeze Bottle is also top-rack dishwasher safe.
Hints for a more comfortable nasal wash
- Begin using the SinuCleanse System slowly. A full pot or bottle of solution
on each side is not necessary to receive the full benefit.
-If the solution is too warm or too cold, the nasal wash will be uncomfortable.
-If stinging or irritation occurs, try using 1/2 of a packet of dry ingredients for the Neti
Pot or 1 packet per Squeeze Bottle of the saline dry ingredients. Gradually work up
to using the solution at full strength. Do not use less than 1/2 packet for the Neti Pot
or 1 packet per Squeeze bottle.
-If you experience ear discomfort after use, try to blow your nose more gently after the
wash. If the problem persists, the openings of your Eustachian tubes may be
particularly wide and the use of the SinuCleanse System may need
to be discontinued.
-Breathe continuously through the mouth when using the SinuCleanse system
to avoid solution draining from the back of the nose into the mouth.
-Some people experience irritation of the skin just insdie the nostrils with repeated
nasal washing. Applying a thin layer of aloe to the inside of the nostrils before or after
the nasal wash will be soothing.
Package Label.Principal Display Panel
* Please review the disclaimer below.