Gelato Perio Maintenance Rinse Concentrate
NDC 68400-206
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Gelato Perio Maintenance Rinse (stannous fluoride) is a UNAPPROVED DRUG OTHER-approved product labeled by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white concentrate for dental administration. This product entry covers the primary NDC 68400-206 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
68400-206
Proprietary Name:
Gelato Perio Maintenance Rinse
Non-Proprietary Name: [1]
Stannous Fluoride
Substance Name: [2]
Stannous Fluoride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Concentrate
- A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
Administration Route(s): [4]
Dental - Administration to a tooth or teeth.
Labeler & Regulatory Data
Labeler Code:
68400
Product Label ID:
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Marketing Timeline
Start Marketing Date: [9]
02-01-2013
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325 - HEAVY LIQUID)
Flavor(s):
Code Structure Chart
Product Details
What is NDC 68400-206?
The NDC code 68400-206 is assigned by the FDA to the product Gelato Perio Maintenance Rinse. It is commonly known by its generic name, stannous fluoride. This pharmaceutical product is labeled by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. and is currently categorized as listed product. The medication is a concentrate administered via dental route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 68400-206-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product must be used under the supervision of a dentist.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- STANNOUS FLUORIDE (UNII: 3FTR44B32Q)
- FLUORIDE ION (UNII: Q80VPU408O) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
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. The UNII codes for the inactive ingredients in this product are:
- GLYCERIN (UNII: PDC6A3C0OX)
- METHYLPARABEN (UNII: A2I8C7HI9T)
- PROPYLPARABEN (UNII: Z8IX2SC1OH)
- SACCHARIN SODIUM (UNII: SB8ZUX40TY)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 1435516 - Gelato Perio Rinse 0.63 % (fluoride ion 0.12 % ) Dental Solution
- RxCUI: 1435516 - stannous fluoride 6.3 MG/ML Mouthwash [Gelato Perio Rinse]
- RxCUI: 1435516 - Gelato Perio Rinse 0.63 % (fluoride ion 0.12 % ) Mouthwash
- RxCUI: 1435516 - Gelato Perio Rinse 6.3 MG/ML Mouthwash
- RxCUI: 583459 - stannous fluoride 0.63 % Dental Solution
* Please review the full disclaimer at the bottom of this page.
Patient Education
Fluoride
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usually is prescribed for children and adults whose homes have water that is not fluoridated (already has fluoride added). This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
