NDC 0295-4807 Cvs Sinus Wash

Sodium Chloride, Sodium Bicarbonate

NDC Product Code 0295-4807

NDC 0295-4807-28

Package Description: 1 KIT in 1 KIT * 3 PACKET in 1 KIT > 3000 mg in 1 PACKET * 1 BOTTLE in 1 KIT > 240 g in 1 BOTTLE

NDC Product Information

Cvs Sinus Wash with NDC 0295-4807 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc. The generic name of Cvs Sinus Wash is sodium chloride, sodium bicarbonate. The product's dosage form is kit and is administered via form.

Labeler Name: Denison Pharmaceuticals, 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)
  • WATER (UNII: 059QF0KO0R)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Product Labeler Information

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

Labeler Name: Denison Pharmaceuticals, Llc
Labeler Code: 0295
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: 02-22-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cvs Sinus Wash Product Label Images

Cvs Sinus Wash 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 prefilled bottle)Sodium Bicarbonate USP 700 mgSodium Chloride USP 2300 mg

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

Otc - Purpose

PurposeNasal Wash

Purpose Nasal 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.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.When using this product:Use by only one personWash with soap and water after each useDo 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 physicianPrior to first use see enclosed instruction sheet for complete directions

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(in each prefilled bottle)Purified Water USP, Benzalkonium Chloride USP (Preservative) Inactive ingredients(in each packet)None

Otc - Questions

Questions?1-888-547-5492

* Please review the disclaimer below.

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