Denti Whoo Cts Gum Caretoothpaste

Silicon Dioxide, Sodium Fluoride, Tocopherol Acetate

Sun Life Science Co Ltd
Human Otc Drug
NDC 86157-0013

Denti Whoo Cts Gum Caretoothpaste also known as Silicon Dioxide, Sodium Fluoride, Tocopherol Acetate is a human otc drug labeled by 'Sun Life Science Co Ltd'. National Drug Code (NDC) number for Denti Whoo Cts Gum Caretoothpaste is 86157-0013. This drug is available in dosage form of Paste, Dentifrice. The names of the active, medicinal ingredients in Denti Whoo Cts Gum Caretoothpaste drug includes .alpha.-tocopherol Acetate - .2 g/100g Silicon Dioxide - 15 g/100g Sodium Fluoride - .22 g/100g . The currest status of Denti Whoo Cts Gum Caretoothpaste drug is Active.

Drug Information:

Drug NDC:	86157-0013
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Denti Whoo Cts Gum Caretoothpaste
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Silicon Dioxide, Sodium Fluoride, Tocopherol Acetate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Sun Life Science Co Ltd
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Paste, Dentifrice
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	.ALPHA.-TOCOPHEROL ACETATE - .2 g/100g SILICON DIOXIDE - 15 g/100g SODIUM FLUORIDE - .22 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	DENTAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	06 Apr, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	09 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	SUN LIFE SCIENCE CO LTD
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	8809513390880
UPC stands for Universal Product Code.
UNII:	9E8X80D2L0 ETJ7Z6XBU4 8ZYQ1474W7
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
86157-0013-1	50 g in 1 TUBE (86157-0013-1)	06 Apr, 2022	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Denti Whoo Cts Gum Caretoothpaste

Silicon Dioxide, Sodium Fluoride, Tocopherol Acetate

Paste, Dentifrice
SUN LIFE SCIENCE CO LTD
NDC: 86157-0013

Purpose:

(1) keep your teeth white and strong.(2) keep your mouth clean.(3) refresh the inside of the mouth.(4) prevent tooth decay and remove bad breath due to fluorine.(5) increase the esthetic effect.(6) prevention of gingivitis and periodontitis(alveolar fistula)(7) prevention of periodontal disease and gum disease(8) plaque removal(anti-plaque)

Product Elements:

Denti whoo cts gum caretoothpaste silicon dioxide, sodium fluoride, tocopherol acetate xylitol water levomenthol sodium fluoride fluoride ion silicon dioxide silicon dioxide .alpha.-tocopherol acetate .alpha.-tocopherol

Indications and Usage:

Brushing the teeth with a suitable amount

Warnings:

(1) the fluoride content of this toothpaste is 1,000 ppm.(2) do not swallow and rinse mouth thoroughly after use(3) if you experience any problems with your gums or mouth during use,discontinue use and consult your doctor(4) for children under 6 years of age, use small amounts of toothpaste. and use itunder the supervision of a guardian to avoid sucking or swallowing(5) consult a physician or dentist immediately if a child under 6 years old hasswallowed large quantities(6) keep out of the reach of children under 6 years of age

Dosage and Administration:

For dental use only

Package Label Principal Display Panel:

Label

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.