NDC 55910-919 Rexall Sinus Wash System Soft Tip Squeeze Bottle

Sodium Bicarbonate, Sodium Chloride

NDC Product Code 55910-919

NDC 55910-919-20

Package Description: 1 KIT in 1 KIT * 3000 mg in 1 PACKET (55910-543-20)

NDC Product Information

Rexall Sinus Wash System Soft Tip Squeeze Bottle with NDC 55910-919 is a a human over the counter drug product labeled by Dolgencorp, Llc. The generic name of Rexall Sinus Wash System Soft Tip Squeeze Bottle is sodium bicarbonate, sodium chloride. The product's dosage form is kit and is administered via nasal form.

Labeler Name: Dolgencorp, Llc

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: Dolgencorp, Llc
Labeler Code: 55910
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: 05-17-2021 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.

Rexall Sinus Wash System Soft Tip Squeeze Bottle Product Label Images

Rexall Sinus Wash System Soft Tip Squeeze Bottle 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 mg)Sodium Chloride USP (2300 mg)

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)Promotes 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 form excessive heat and moisture-See saline packets or box for lot number and expiration date
Questions?1-888-4-REXALL

Inactive Ingredient

Inactive IngredientsNone

Instructions For Use

Instructions for Use of the SinuCleanse SqueezeDirections: 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 SqueezeBottle. First-time users should start with 1 packet of the saline dryingredients. As you become more accustomed to the system, work upto using 2 full packets. Additional packets may be purchased from yournearest pharmacy.3. Fill the bottle with a proper water source * leaving approximately 1/2 inchof 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 gentlyshake 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. Placethe tip of the cap up to the right nostril and gently insert the tip so that it forms a comfortableseal. 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 squeezethe 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 nostrilsto 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 drycompletely. 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 solutionon 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 NetiPot or 1 packet per Squeeze Bottle of the saline dry ingredients. Gradually work upto using the solution at full strength. Do not use less than 1/2 packet for the Neti Potor 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 needto be discontinued.











-Breathe continuously through the mouth when using the SinuCleanse systemto avoid solution draining from the back of the nose into the mouth.-Some people experience irritation of the skin just insdie the nostrils with repeatednasal washing. Applying a thin layer of aloe to the inside of the nostrils before or afterthe nasal wash will be soothing.

* Please review the disclaimer below.