NDC 0363-1505 Walgreens Saline Mist Extra Strength

Sodium Chloride

NDC Product Code 0363-1505

NDC 0363-1505-60

Package Description: 129 g in 1 BOTTLE, SPRAY

NDC Product Information

Walgreens Saline Mist Extra Strength with NDC 0363-1505 is a a human over the counter drug product labeled by Walgreen's Corporation. The generic name of Walgreens Saline Mist Extra Strength is sodium chloride. The product's dosage form is spray and is administered via nasal form.

Labeler Name: Walgreen's Corporation

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Walgreens Saline Mist Extra Strength Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM CHLORIDE 3 g/100g

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: Walgreen's Corporation
Labeler Code: 0363
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: 08-22-2019 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’.

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Walgreens Saline Mist Extra Strength Product Label Images

Walgreens Saline Mist Extra Strength 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

Active Ingredient

Sodium Chloride 3.0%Sterile, Hypertonic Saline Solution, Sodium Bicarbonate to adjust pH

Purpose

Nasal Wash

Inactive Ingredients

Purfied Water

Uses

  • Nasal congestionRemoves inhaled irritants (dust, dirt, pollen)Moisturizes dry nasal passages

Directions

For nasal use only. Before use, expel a shoet stream of mist into the air. Insert tip of nozzle into one nostril and press down on the textured area at the base of the nozzle so that a gentle mist coats nasal passages. Blow your nose very gently to clear the mucus out. Repeat for the other nostriil. To flush and irrigate, tilt head to the side over sink. Insert top of nozzle into the top nostril, pressing down on the textured area at the base of the nozzle so that a gentle mist fills sinus passages and flows out the opposite nostril. Repeat in other nostril. Wipe nozzle after each use. USE AS OFTEN AS NEEDED NON-HABIT FORMINGNON-ADDICTING

Warnings

  • WarningsUse of this product by more than one person may spread infectionContents under pressureDo not puncture or incinerateAvoid spraying in eyes

Keep Out Of Reach Of Chlidren.

Adults and children 4 years and over:Use as often as neededChildren under 4 years: Consult a physicianSee directions on can for complere instructions

* Please review the disclaimer below.