NDC 59262-245 Kids Nasal Allergy Relief

Cardiospermum Halicacabum Flowering Top, Galphimia Glauca Flowering Top, Luffa Operculata Fruit And Schoenocaulon Officinale Seed

NDC Product Code 59262-245

NDC Code: 59262-245

Proprietary Name: Kids Nasal Allergy Relief 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: Cardiospermum Halicacabum Flowering Top, Galphimia Glauca Flowering Top, Luffa Operculata Fruit And Schoenocaulon Officinale Seed 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

  • 59262 - Similasan Corporation
    • 59262-245 - Kids Nasal Allergy Relief

NDC 59262-245-20

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 20 mL in 1 BOTTLE, SPRAY

NDC Product Information

Kids Nasal Allergy Relief with NDC 59262-245 is a a human over the counter drug product labeled by Similasan Corporation. The generic name of Kids Nasal Allergy Relief is cardiospermum halicacabum flowering top, galphimia glauca flowering top, luffa operculata fruit and schoenocaulon officinale seed. The product's dosage form is spray and is administered via nasal form.

Labeler Name: Similasan 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.

Kids Nasal Allergy Relief 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.

  • CARDIOSPERMUM HALICACABUM FLOWERING TOP 6 [hp_X]/20mL
  • GALPHIMIA GLAUCA FLOWERING TOP 6 [hp_X]/20mL
  • LUFFA OPERCULATA FRUIT 6 [hp_X]/20mL
  • SCHOENOCAULON OFFICINALE SEED 6 [hp_X]/20mL

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)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: Similasan Corporation
Labeler Code: 59262
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 02-15-2019 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.

Kids Nasal Allergy Relief 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 Ingredients

Cardiospermum 6XGalphimia glauca 6XLuffa operculata 6XSabadilla 6X

Purpose

Itching, runny noserunny nose, watery eyes, sneezingrunny nose, sinus congestionsneezing, itching

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:• allergies accompanied by runny nose, itching and/or burning of the nose, watery eyes, sneezing and swollen mucous membranes (congestion)• post nasal drip caused by allergies• sinus pressure caused by allergies

Warnings

• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).• Replace cap tightly after every use.• To avoid contamination, do not touch the tip of the container to any surface besides nose.• Discard open bottle after 6 months.• The use of this container by more than one person may spread infection.

If Pregnant, Trying To Get Pregnant Or Breast Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You:

• are susceptible to nose bleeds• are prone to ear, nose or throat sensitivity

Stop Use And Ask A Doctor If:

• symptoms worsen or persist for more than 72 hours

Directions

For adults and children ages 2 and over:• Remove tamper-evident plastic seal from bottle• Lift cap off bottle• Spray 1-3 times into each nostril• Use as needed• Replace cap after use

Other Information

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

Purified water, Sodium chloride

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.www.SimilasanUSA.com

* Please review the disclaimer below.

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