NDC 61596-100 Mipasteone Kids Blue Raspberry

Mi Paste One Kids Blue Raspberry

NDC Product Code 61596-100

NDC CODE: 61596-100

Proprietary Name: Mipasteone Kids Blue Raspberry What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Mi Paste One Kids Blue Raspberry 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.

Product Characteristics

Flavor(s):
RASPBERRY (C73413)

NDC Code Structure

  • 61596 - Gc America Inc.

NDC 61596-100-10

Package Description: 10 BOX, UNIT-DOSE in 1 BOX > 1 TUBE in 1 BOX, UNIT-DOSE (61596-100-41) > 46 g in 1 TUBE (61596-100-40)

NDC Product Information

Mipasteone Kids Blue Raspberry with NDC 61596-100 is a a human over the counter drug product labeled by Gc America Inc.. The generic name of Mipasteone Kids Blue Raspberry is mi paste one kids blue raspberry. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Gc America Inc.

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

Product Type: Human Otc Drug 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.

Mipasteone Kids Blue Raspberry Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM FLUORIDE .24 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • WATER (UNII: 059QF0KO0R)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • XYLITOL (UNII: VCQ006KQ1E)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • GLYCEROL FORMAL (UNII: 3L7GR2604E)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
  • SORBITOL (UNII: 506T60A25R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Gc America Inc.
Labeler Code: 61596
FDA Application Number: part355 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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.

Start Marketing Date: 04-09-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 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.

Exclude Flag: N - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Mipasteone Kids Blue Raspberry Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Dosage & Administration

For adults and children 2

years of age or older, apply a small,

pea-size amount of MI Paste ONE

Kids to your toothbrush. For best

results, brush for 2 minutes,

expectorate and avoid eating or

drinking for 30 minutes after brushing.

Use twice daily. Replace cap after

use. For children under 2 years of age,

consult a dentist or physician.

Warnings

Warning Keep out of reach of

children under 6 years of age. 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.

Inactive Ingredient

Inactive ingredients Pure water,

Glycerol, RECALDENT CPP-ACP

Casein Phosphopeptide-Amorphous

Calcium Phosphate, Sorbitol,

CMC-Na, Propylene glycol, Silicon

dioxide, Titanium dioxide, Xylitol,

Phosphoric acid, Flavoring, Sodium

saccharin, Ethyl p-hydroxybenzoate,

Propyl p-hydroxybenzoate, Butyl

p-hydroxybenzoate, Sodium-N-lauroyl

sarcosinate.

Otc - Active Ingredient

Active ingredient Sodium Fluoride 0.24% w/wPurpose Anti-cavity

Indications & Usage

Use

- aids in the prevention of dental

cavities

Otc - Keep Out Of Reach Of Children

Warning Keep out of reach of

children under 6 years of age. 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.

Otc - Purpose

Use

- aids in the prevention of dental

cavities

* Please review the disclaimer below.