NDC 42829-402 Sinucleanse Neti-pot

Sodium Bicarbonate, Sodium Chloride

NDC Product Code 42829-402

NDC 42829-402-30

Package Description: 1 KIT in 1 KIT * 3000 mg in 1 PACKET (42829-401-01)

NDC Product Information

Sinucleanse Neti-pot with NDC 42829-402 is a a human over the counter drug product labeled by Ascent Consumer Products, Inc.. The generic name of Sinucleanse Neti-pot is sodium bicarbonate, sodium chloride. The product's dosage form is kit and is administered via nasal form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1542919.

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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Nasal - Administration to the nose; administered by way of the nose.

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: 02-01-2015 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 Neti-pot Product Label Images

Sinucleanse Neti-pot 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 - Purpose

PurposeNasal Wash

Indications & Usage

UsesTemporarily relieves symptoms associated withsinusitis, cold, flu or allergies-Sneezing-Nasal Stuffiness-Runny nose-Post nasal dripRemoves inhaled irritants (dust, pollen)Removes nasal and sinus drainageHelps reduce swelling of nasal membranesMoisturizes dry nasal passages

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Warnings

WarningsStop use and ask a doctor if washing is uncomfortableor symptoms are not relieved.Do not use unfiltered tap water. see instructions inside box for proper water sourcesDo not use if nasal passages are completely blocked or if you have an ear infection or blocked ears.

Dosage & Administration

DirectionsAdults 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 physicianSee 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 IngredientsNone

Instructions For Use

Instructions for Use of the SinuCleanse Neti PotDirections: 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 ofthe SinuCleanse dry ingredients. As you become more accustomed tothe system, work up to using 1 full packet. Additional packets may bepurchased 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 themof 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 hasbeen distilled, sterilized, filtered or previously boiled and leave the








pot to air dry completely. The SinuCleanse Neti Pot is top-rack dishwasher safe.

* Please review the disclaimer below.