FDA Label for Sinucleanse Micro-filtered Nasal Wash System

Otc - Active Ingredient

Active ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

Otc - Purpose

Purpose

Nasal Wash

Indications & Usage

Uses

Temporarily relieves symptoms associated with

sinusitis, cold, flu or allergies:

-Sneezing

-Runny nose

-Nasal stuffiness

-Post nasal drip

-Removes inhaled irritants (dust, pollen)

-Promotes nasal and sinus drainage

-Helps reduce swelling of nasal membranes

-Moisturizes dry nasal passages

Warnings

Warnings

Stop use and ask a doctor if washing is uncomfortable or

symptoms are not reduced.

When used with tap water see instructions inside box

for proper water sources.

When using this product:

• Use by only one person
• Wash with soap and water after each use
• Top rack of dishwasher safe
• Do not heat in microwave

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

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 no. and expiration date
  

Inactive Ingredient

Inactive ingredients: none

Otc - Questions

Questions?

1-888-547-5492

Instructions For Use

Filter Data
Model #’s:
91-40630, 97-40630, 98-40630
Manufacturer:
Ascent Consumer Products Inc.
Melville NY 11737
888-547-5492
Distributed by:
See Box for Information
Filter Type:
Mechanical Cyst Reduction Filter
Maximum Operating Temperature:
100 degrees Fahrenheit
Maximum Working Pressure:
5 psi
Maximum Service Life:
50 gallons
This product has been tested and certified to meet NSF/ANSI Standard
53, a drinking water standard, for cyst reduction of 99.95% and to be
lead free.
For more information from the Centers for Disease Control and Prevention (CDC)
on water filters and sinus washing visit the CDC web site at: http://www.cdc.gov.
Micro-Filtered
Sinus Wash System
Please read instructions thoroughly before
using and keep for future reference.

NEW!
BUILT IN WATER
FILTER
About the Micro-Filtered Sinus Wash System
The Micro-Filtered Sinus Wash System is a revolutionary new
product that makes receiving the proven benefits of sinus
washing easier than ever. The built in water filter meets the
CDC recommendation for sinus washing with tap water*. This
provides peace of mind, while also eliminating the cost of
bottled water or the inconvenience of boiling and pre-filtering
tap water. It also allows for easier temperature control of the
saline solution for a soothing and more comfortable sinus wash

The patent pending Micro-Filtered System incorporates
additional innovations to maximize the comfort and
convenience of sinus washing:
• Inverted filter technology with anti-backflow valve uses a
combination of gravity and positive pressure to provide an
easy to control and comfortable flow of the saline solution.
• Ergonomically designed bottle and soft nasal tip are
comfortable to use and easy to clean.

Frequently asked questions and important information
about the Micro-Filtered Sinus Wash System Warning: Do not use Micro-Filtered System if nasal passages are
completely blocked.
Preparing the Micro-Filtered System for first use
Before first use rinse the bottle with warm tap water and empty. Next fill bottle
with warm tap water and place cap on bottle and tighten securely. Holding the
assembled bottle and cap over the sink, invert so comfort tip faces up and squeeze
bottle several times until bottle is empty and no water flows from the comfort tip.
Repeat the filling and emptying process two additional times. The Micro-Filtered
System is now ready for use.
What type of water can be used in the Micro-Filtered System?
In addition to distilled water or commercially bottled water the Micro-Filtered System
can be used with tap water. WARNING: The Micro-Filtered System is intended as a
final filter for tap water that is known to be safe for drinking.
How do I clean the Micro-Filtered System?
Do not clean any part of the Micro-Filtered System in the dishwasher.
Cleaning the bottle: Rinse the bottle out with water after each use and allow to dry.
Cleaning the comfort tip: Remove tip and clean with soap and water after each use.
Replace tip after cleaning.
Cleaning the cap: The outside of the cap can be rinsed with water and dried.
Can I share the Micro-Filtered System with friends and family?
The Micro-Filtered System is intended for individual use and not to be shared.

How do I clean the Micro-Filtered System?
Do not clean any part of the Micro-Filtered System in the dishwasher.
Cleaning the bottle: Rinse the bottle out with water after each use and allow to dry.
Cleaning the comfort tip: Remove tip and clean with soap and water after each use.
Replace tip after cleaning.
Cleaning the cap: The outside of the cap can be rinsed with water and dried.

Should I use an Isotonic or Hypertonic solution?
The Micro-Filtered System can be used with the enclosed saline packets to make either
an Isotonic or Hypertonic solution. An Isotonic solution has a salt concentration similar
to your body and some people find this more comfortable to use. A Hypertonic
solution is more concentrated, similar to the salt concentration of ocean water. Both
are beneficial to your sinus and nasal health.
Check with the guide below or consult with your physician for best use.

Check with the guide below or consult with your physician for best use.
Isotonic Solution 1 Saline Packet per
8 fl oz
Hypertonic Solution
2 Saline Packets per
8 fl oz
Helpful hints for a more comfortable sinus wash experience:
• Begin using the Micro-Filtered System slowly – especially with children. A full
bottle of solution is not necessary to receive the full benefit.
• If the solution is too warm or too cold, the Sinus Wash will be uncomfortable.
• If stinging or irritation occurs, try using 1 packet of dry ingredients per
bottle. Gradually work up to using the solution at full strength using 2 full packets
per bottle. Do not use less than 1 packet.
• If you experience ear discomfort after use, try to blow your nose gently after the
wash. If the problem persists, the openings of your Eustachian tubes may be
particularly wide and use of the system should be discontinued.
• Breathe continuously through the mouth when using the Sinus Wash System to
avoid solution draining from the back of the nose into the mouth.

Instructions for Use:
1. Wash your hands and make sure the Micro-Filtered System has been prepared
according to the instructions above before first use.
2. Pour the contents of the saline packet(s) into the bottle. First-time users should start
with 1 packet to make an Isotonic solution. As you become more accustomed to
using the system, you may work up to using 2 full packets for a Hypertonic solution.
Additional packets may be purchased online or from your nearest pharmacy.
3. Fill the bottle with warm tap water to the 8 oz mark indicated on the bottle. Test
water temperature before using.
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 comfort tip 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. When finished hold the system inverted over sink and squeeze several times to
remove solution remaining in cap.
11. Holding the cap assembly over the sink unscrew filter (B) by turning the white ring on bottom
of cap counter clockwise while holding cap (A). Empty any remaining solution into the sink
and allow to dry. Reassemble the filter making sure the black O-ring (C) is seated above the
filter base threads as shown in the illustration below. After each use please clean system.
Clean the bottle: Rinse the bottle out with water and allow to dry.
Clean the comfort tip: Remove tip and clean with soap and water and reinstall.
Clean the cap: The outside of the cap can be rinsed with water and dried.

Package Label.Principal Display Panel

image description - Sinucleanse2 label