NDC 80762-0004 Bye Bye (toc Toc)

Sodium Chloride

NDC Product Code 80762-0004

NDC CODE: 80762-0004

Proprietary Name: Bye Bye (toc Toc) 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: Sodium Chloride 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

NDC Code Structure

  • 80762 - Korea Bio Science

NDC 80762-0004-1

Package Description: 300 mL in 1 BOTTLE, SPRAY

NDC Product Information

Bye Bye (toc Toc) with NDC 80762-0004 is a a human over the counter drug product labeled by Korea Bio Science. The generic name of Bye Bye (toc Toc) is sodium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Korea Bio Science

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Bye Bye (toc Toc) 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 2.97 g/300mL

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.

  • NORI (UNII: 477TV3P5UX)
  • MAGNESIUM (UNII: I38ZP9992A)
  • CALCIUM (UNII: SY7Q814VUP)
  • POTASSIUM (UNII: RWP5GA015D)
  • SULFATE ION (UNII: 7IS9N8KPMG)
  • 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.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Korea Bio Science
Labeler Code: 80762
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: 10-06-2020 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: 12-31-2021 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.

Bye Bye (toc Toc) Product Label Images

Bye Bye (toc Toc) 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

Sodium Chloride

Inactive Ingredient

Kelp extract, Seaweed extract, magnesium extract, calcium extract, potassium extract, sulfate ion extract, water

Otc - Purpose

Hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Place enough product on hadns to cover all surfaces. rub hands together until dry.supervise children uner 6 years of age when using this product to avoid swallowing.

Warnings

Stop use and ask a doctor if irritation or rash occurs.Keep out of reach of children.

Dosage & Administration

For external use only

* Please review the disclaimer below.