NDC 82351-0001 Lath Nonistoothpaste

Sodium Monofluorophosphate

NDC Product Code 82351-0001

NDC 82351-0001-1

Package Description: 160 g in 1 TUBE

NDC Product Information

Lath Nonistoothpaste with NDC 82351-0001 is a a human over the counter drug product labeled by Sa Group Co Ltd. The generic name of Lath Nonistoothpaste is sodium monofluorophosphate. The product's dosage form is paste and is administered via oral form.

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Lath Nonistoothpaste 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.


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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL (UNII: 506T60A25R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Sa Group Co Ltd
Labeler Code: 82351
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: 11-05-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Lath Nonistoothpaste Product Label Images

Lath Nonistoothpaste 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 MONOFLUOROPHOSPHATE

Inactive Ingredient

HYDRATED SILICA

TETRASODIUM PYROPHOSPHATE

TOCOPHERYL ACETATE

SORBITOL

SODIUM PCA

GLUCOSYL STEVIOSIDE

XYLITOL

GLYCERIN

CELLULOSE GUM

SODIUM LAUROYL SARCOSINATE

SCUTELLARIA BAICALENSIS ROOT EXTRACT

MORINDA CITRIFOLIA FRUIT EXTRACT

PISTACIA LENTISCUS (MASTIC) GUM

SALIVA OFFICINALIS (SAGE) EXTRACT

CAMELLIA SINENSIS LEAF EXTRACT

ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT

ANTHEMIS NOBILIS FLOWER EXTRACT

CALENDULA OFFICINALIS FLOWER EXTRACT

COMMIPHORA MYRRHA RESIN EXTRACT

CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT

KRAMERIA TRIANDRA ROOT EXTRACT

PROPOLIS EXTRACT

MENTHOL

MENTHA PIPERITA (PEPPERMINT) OIL

MENTHA VIRIDIS (SPEARMINT) LEAF OIL

FLAVOR

FLAVOR

WATER

Purpose

Tooth whitening, tooth decay prevention, bad breath removal. Makes teeth strong. Keeps the mouth clean. Refreshes the inside of the mouth. Increases the aesthetic effect. Prevention of periodontal disease, prevention of gum disease, removal of plaque(anti-plaque)

Keep Out Of Reach Of Children

Keep out of reach of children.

Warning

For oral use only

When using this product
■ Do not use other than brushing teeth and be careful not to swallowKeep out of reach of children■ if swallowed, seek medical help or contact the poison control center immediately

Uses

For oral use only

Indication & Usage Section

Brush thoroughly ofter each meal or at least twice a day, as directed by yourdoctorordendst

Do not swallow.
Do not use if seal is broken or missing.store in a cool, dry place.

* Please review the disclaimer below.