Kids Choice
Stannous Fluoride
Massco Dental A Division Of Dunagin Pharmaceuticals
Human Prescription Drug
NDC 63783-005Kids Choice also known as Stannous Fluoride is a human prescription drug labeled by 'Massco Dental A Division Of Dunagin Pharmaceuticals'. National Drug Code (NDC) number for Kids Choice is 63783-005. This drug is available in dosage form of Gel, Dentifrice. The names of the active, medicinal ingredients in Kids Choice drug includes Stannous Fluoride - .12 g/120g . The currest status of Kids Choice drug is Active.
Drug Information:
| Drug NDC: | 63783-005 |
| 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: | Kids Choice |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Stannous Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Massco Dental A Division Of Dunagin Pharmaceuticals |
| 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: | STANNOUS FLUORIDE - .12 g/120g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| 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: | 01 Jan, 1989 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2023 |
| 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: | 20 Dec, 2025 |
| 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: | Massco Dental A Division of Dunagin Pharmaceuticals
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 237847
1037034
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 3FTR44B32Q
|
| 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 |
|---|
| 63783-005-04 | 120 g in 1 BOTTLE, DISPENSING (63783-005-04) | 01 Jan, 1989 | 31 Dec, 2023 | 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. |
Product Elements:
Kids choice stannous fluoride stannous fluoride fluoride ion glycerin hydroxyethyl cellulose (2000 cps at 1%) xylitol bubble gum kids choice stannous fluoride stannous fluoride fluoride ion glycerin hydroxyethyl cellulose (2000 cps at 1%) xylitol hint of mint kids choice stannous fluoride stannous fluoride fluoride ion glycerin hydroxyethyl cellulose (2000 cps at 1%) xylitol limeaide kids choice stannous fluoride stannous fluoride fluoride ion glycerin hydroxyethyl cellulose (2000 cps at 1%) xylitol grape kids choice stannous fluoride stannous fluoride fluoride ion glycerin hydroxyethyl cellulose (2000 cps at 1%) xylitol cherry
Indications and Usage:
Use aids in the prevention of dental decay.
Warnings:
Warnings if more than amount used for brushing is accidentally swallowed, seek medical help from a poison control center.
When Using:
Directions for use adults and children 12 years and older: use after regular brushing and flossing. place gel across length of toothbrush. brush thoroughly. keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out). do not swallow. use once a day for cavity prevention. supervise children until capable of using without supervision. children 6-11 years: see directions above. adult supervision required. children under 6: consult a dentist or physician.
General Precautions:
Other information this is a fluoride prevention treatment gel, not a toothpaste. read directions carefully before use. this product may produce surface discoloration of the teeth. adequate toothbrushing may prevent discoloration. discoloration is not harmful or permanent and may be removed by a dental professional. do not freeze or expose to extreme heat.
Package Label Principal Display Panel:
Package label brush on therapy for cavity prevention - doctor's choice 0.4% stannous fluoride gel manufactured by massco dental grape label bubble gum label limeaide label mint label cherry label
Further Questions:
Questions ? comments ? questions?? comments?? call 1-479-787-5168 m-f 9am to 5pm cst