NDC 55409-002 Amino Acid Fragrancemouthwash Dawn

Oral Rinses

NDC Product Code 55409-002

NDC CODE: 55409-002

Proprietary Name: Amino Acid Fragrancemouthwash Dawn 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: Oral Rinses 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 medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

  • 55409 - Shanghai Centro Network Technology Co., Ltd.
    • 55409-002 - Amino Acid Fragrancemouthwash Dawn

NDC 55409-002-01

Package Description: 10 mL in 1 VIAL

NDC Product Information

Amino Acid Fragrancemouthwash Dawn with NDC 55409-002 is a a human over the counter drug product labeled by Shanghai Centro Network Technology Co., Ltd.. The generic name of Amino Acid Fragrancemouthwash Dawn is oral rinses. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Shanghai Centro Network Technology Co., Ltd.

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.

Amino Acid Fragrancemouthwash Dawn 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 FLUORIDE .005 g/10mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • VERBENA OFFICINALIS (UNII: QT8A71T9BM)
  • ARGININE (UNII: 94ZLA3W45F)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • SORBITOL (UNII: 506T60A25R)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • PRUNUS SPECIOSA FLOWER (UNII: A78OOO9299)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • MENTHOL (UNII: L7T10EIP3A)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)

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: Shanghai Centro Network Technology Co., Ltd.
Labeler Code: 55409
FDA Application Number: part355 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 10-19-2020 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.

Amino Acid Fragrancemouthwash Dawn Product Label Images

Amino Acid Fragrancemouthwash Dawn 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

Dosage & Administration

Keep in a cool and dry place and aviod storage in direct sunlight.

Inactive Ingredient

AQUA、SORBITOL、GLYCERIN、POLOXAMER 407、PRUNUS SPECIOSA FLOWER EXTRACT、VERBENA OFFICINALIS EXTRACT、MENTHOL、 MENTHONE GLYCERIN ACETAL、ARGININE、SUCRALOSE、PROPYLENE GLYCOL、 BUTYLENE GLYCOL、POLYSORBATE 20、CETYLPYRIDINIUM CHLORIDE、CITRIC ACID、 FLAVOR、SODIUM BENZOATE

Indications & Usage

It is recommended to use one(10ml) at a time, gargle for 30 seconds and spit out It's no need to garglewith water after use.

Otc - Active Ingredient

SODIUM FLUORIDE

Otc - Do Not Use

Don't swallow it.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Purpose

Gargle

Warnings

Stopuse and aska doctor when feelinguncomfortable.

* Please review the disclaimer below.