Mipaste One Perio
Gc America Inc.
Human Otc Drug
NDC 61596-300Mipaste One Perio is a human otc drug labeled by 'Gc America Inc.'. National Drug Code (NDC) number for Mipaste One Perio is 61596-300. This drug is available in dosage form of Paste, Dentifrice. The names of the active, medicinal ingredients in Mipaste One Perio drug includes Stannous Fluoride - .454 g/100g . The currest status of Mipaste One Perio drug is Active.
Drug Information:
| Drug NDC: | 61596-300 |
| 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: | Mipaste One Perio |
| 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: | Mipaste One Perio |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Gc America Inc. |
| 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: | STANNOUS FLUORIDE - .454 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: | OTC MONOGRAPH 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: | 01 Feb, 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. |
| Application Number: | part355 |
| 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: | GC America Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 416784
|
| 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 |
|---|
| 61596-300-10 | 10 BOTTLE, UNIT-DOSE in 1 BOX (61596-300-10) / 1 TUBE in 1 BOTTLE, UNIT-DOSE (61596-300-41) / 42 g in 1 TUBE (61596-300-40) | 01 Feb, 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. |
Purpose:
Purposes anti-gingivitis anti-cavity anti-sensitivity
Product Elements:
Mipaste one perio mipaste one perio stannous fluoride fluoride ion water calcium phosphate, unspecified form carboxymethylcellulose sodium, unspecified glycerin silicon dioxide saccharin sodium ethylparaben propylene glycol sorbitol sodium lauryl sulfate xylitol propylparaben butylparaben sodium citrate, unspecified form titanium dioxide
Indications and Usage:
Uses ⢠helps prevent gingivitis ⢠helps interfere with harmful effects of plaque associated with gingivitis ⢠aids in the prevention of cavities ⢠builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
Warnings:
⢠keep out of reach of children ⢠stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks, or if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. these may be signs of periodontitis, a serious form of gum disease. ⢠when using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist. ⢠if more than the recommended amount of paste used for brushing is accidentally swallowed, get medical help or contact a poison control center right away. do not use on patients with a milk protein or hydroxybenzoates allergy. in case of allergic reaction, stop use, rinse mouth with water and seek medical advice.
Dosage and Administration:
For adults and children 12 years of age or older, apply a small, pea-size amount of mi paste one perio to your toothbrush. for best results, brush for 2 minutes, expectorate and do not rinse; do not eat or drink for 30 minutes after brushing. use twice daily. replace cap after use. for children under 12 years of age, consult a dentist or physician.
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