NDC 42829-406 Sinucleanse Micro-filtered Nasal Wash System

Sodium Chloride, Sodium Bicarbonate

NDC Product Code 42829-406

NDC CODE: 42829-406

Proprietary Name: Sinucleanse Micro-filtered Nasal Wash System What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sodium Chloride, Sodium Bicarbonate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 42829 - Ascent Consumer Products, Inc.
    • 42829-406 - Sinucleanse Micro-filtered Nasal Wash System

NDC 42829-406-30

Package Description: 1 KIT in 1 KIT * 30 PACKET in 1 KIT (42829-401-02) > 3000 mg in 1 PACKET

NDC Product Information

Sinucleanse Micro-filtered Nasal Wash System with NDC 42829-406 is a a human over the counter drug product labeled by Ascent Consumer Products, Inc.. The generic name of Sinucleanse Micro-filtered Nasal Wash System is sodium chloride, sodium bicarbonate. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1542919 and 1866164.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ascent Consumer Products, Inc.
Labeler Code: 42829
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-01-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Sinucleanse Micro-filtered Nasal Wash System Product Label Images

Sinucleanse Micro-filtered Nasal Wash System Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active ingredients(in each packet)Sodium Bicarbonate USP 700 mgSodium Chloride USP 2300 mg

Otc - Purpose

PurposeNasal Wash

Indications & Usage

UsesTemporarily relieves symptoms associated withsinusitis, 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

  • WarningsStop use and ask a doctor if washing is uncomfortable orsymptoms are not reduced.When used with tap water see instructions inside box for proper water sources.When using this product:
  • Use by only one personWash with soap and water after each useTop rack of dishwasher safeDo 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 neededChildren under 4 years:  Consult a physicianSee enclosed instruction sheet for complete directions and proper use

Other Safety Information

  • Other informationInspect saline packets for integrityDo not use saline packets if open or tornProtect saline packets from excessive heat and moistureSee 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 DataModel #’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-FilteredSinus Wash SystemPlease read instructions thoroughly beforeusing and keep for future reference.








NEW!BUILT IN WATERFILTERAbout the Micro-Filtered Sinus Wash SystemThe 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 incorporatesadditional innovations to maximize the comfort andconvenience 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 informationabout the Micro-Filtered Sinus Wash System Warning: Do not use Micro-Filtered System if nasal passages arecompletely blocked.








Preparing the Micro-Filtered System for first useBefore 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 Solution2 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 preparedaccording 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.

* Please review the disclaimer below.