Clinplant

Edta Disodium Salt

Nibec Co., Ltd
Human Otc Drug
NDC 47649-0002

Clinplant also known as Edta Disodium Salt is a human otc drug labeled by 'Nibec Co., Ltd'. National Drug Code (NDC) number for Clinplant is 47649-0002. This drug is available in dosage form of Gel, Dentifrice. The names of the active, medicinal ingredients in Clinplant drug includes Edetate Disodium - 24 g/100g . The currest status of Clinplant drug is Active.

Drug Information:

Drug NDC:	47649-0002
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:	Clinplant
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:	Edta Disodium Salt
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Nibec Co., Ltd
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel, 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:	EDETATE DISODIUM - 24 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:	20 Jun, 2018
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:	Nibec 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:	7FLD91C86K
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.
Pharmacologic Class:	Anti-coagulant [EPC] Calcium Chelating Activity [MoA] Decreased Coagulation Factor Activity [PE] Lead Chelating Activity [MoA] Lead Chelator [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
47649-0002-1	4 g in 1 BOX (47649-0002-1)	25 Jun, 2018	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

Clinplant

Edta Disodium Salt

Gel, Dentifrice
Nibec Co., Ltd
NDC: 47649-0002

Purpose:

Nibec clinplant is convenient gel type fomlulation, patented by nibec, for prevention of plaque accumulation and gingival inflammation.nibec cinplant can remove dental plaque, inhibit the growth of periodontal pathogen, and alleviate gingival inflammation

Product Elements:

Clinplant edta disodium salt sodium bicarbonate octoxynol 9 water cetylpyridinium chloride edetate disodium edetic acid carboxymethylcellulose sodium

Indications and Usage:

1. remove the plastic cap of the syringe. 2. carefully install the supplied application tip (shaped like needle). 3. apply to appropriate oral area such as interproximal space and area surrounding dental implants. 4. gently rub for 1 -2 minutes and rinse the applied area with saline. < with microbrush > 1. small quantity of clinplant gel is placed on microbrush. 2 apply to the lntl!rproxlmal area (of tooth or implant) with a mlcrobrush. 3.gentlyrubfor 1-2 minutes and rinse the applied area with sallne. â¢ for better results, please instruct your patients to regularly visit the dental clinic and also to use clinplant floss (cf-1) at home everyday

Warnings:

1. the proximal brush is washed well and dried after using. 2. small amount of clinplant is enough for interproximal brush. 3. do not swallow. 4. do not use in children under the age of 6.

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.