Beanguard Sensitivetoothpaste

Hydrated Silica, Potassium Nitrate, Sodium Fluoride

Bio3s Co.,ltd.
Human Otc Drug
NDC 77935-401

Beanguard Sensitivetoothpaste also known as Hydrated Silica, Potassium Nitrate, Sodium Fluoride is a human otc drug labeled by 'Bio3s Co.,ltd.'. National Drug Code (NDC) number for Beanguard Sensitivetoothpaste is 77935-401. This drug is available in dosage form of Paste, Dentifrice. The names of the active, medicinal ingredients in Beanguard Sensitivetoothpaste drug includes Hydrated Silica - 17.5 g/100mL Potassium Nitrate - 5 g/100mL Sodium Fluoride - .221 g/100mL . The currest status of Beanguard Sensitivetoothpaste drug is Active.

Drug Information:

Drug NDC:	77935-401
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:	Beanguard Sensitivetoothpaste
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:	Hydrated Silica, Potassium Nitrate, Sodium Fluoride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Bio3s 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:	HYDRATED SILICA - 17.5 g/100mL POTASSIUM NITRATE - 5 g/100mL SODIUM FLUORIDE - .221 g/100mL
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:	OTC MONOGRAPH NOT FINAL
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:	27 Dec, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 Dec, 2025
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.
Application Number:	part356
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.
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:	BIO3S 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.
UNII:	Y6O7T4G8P9 RU45X2JN0Z 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
77935-401-01	120 mL in 1 TUBE (77935-401-01)	27 Dec, 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

Beanguard Sensitivetoothpaste

Hydrated Silica, Potassium Nitrate, Sodium Fluoride

Paste, Dentifrice
BIO3S Co.,Ltd.
NDC: 77935-401

Purpose:

Purposes hydrated silica 17.5% antiplaque potassium nitrate 5% antihypersensitivity sodium fluoride 0.221% anticavity

Product Elements:

Beanguard sensitivetoothpaste hydrated silica, potassium nitrate, sodium fluoride glycerin sodium cocoyl glutamate maritime pine potassium nitrate nitrate ion stevioside menthol soybean water xylitol sodium methyl cocoyl taurate tribasic calcium phosphate sodium fluoride fluoride ion hydrated silica hydrated silica sorbitol eucalyptol chamomile eucalyptus globulus leaf rosemary calendula officinalis flower brassica oleracea whole carboxymethylcellulose sodium, unspecified form centella asiatica triterpenoids aloe vera leaf

Indications and Usage:

Uses â builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact â aids in the prevention of dental cavities â helps interfere with harmful effects of plaque associated with gingivitis

Warnings:

Warnings do not use it for purposes other than intended. keep out of reach of children under 6 years of age. if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away. stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

Do Not Use:

When Using:

Warnings if more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

Dosage and Administration:

Directions â adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). supervise children as necessary until capable of using without supervision. children under 2 years of age: consult a dentist or doctor.

Stop Use:

Warnings stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

Package Label Principal Display Panel:

Display panel toothpaste 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.