NDC 80486-111 Kindfill

Mint Toothpaste Tablets

NDC Product Code 80486-111

NDC CODE: 80486-111

Proprietary Name: Kindfill 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: Mint Toothpaste Tablets 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
NONE
Score: 1
Flavor(s):
PEPPERMINT (C73408)

NDC Code Structure

NDC 80486-111-11

Package Description: 60 BOX, UNIT-DOSE in 1 BOX > 312 mg in 1 BOX, UNIT-DOSE

NDC Product Information

Kindfill with NDC 80486-111 is a a human over the counter drug product labeled by Make Usa Llc. The generic name of Kindfill is mint toothpaste tablets. The product's dosage form is tablet, chewable and is administered via dental form.

Labeler Name: Make Usa Llc

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

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.

Kindfill 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 .45 mg/312mg

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.

  • STEVIA LEAF (UNII: 6TC6NN0876)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • MINT (UNII: FV98Z8GITP)
  • MENTHOL, (+)- (UNII: C6B1OE8P3W)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)

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.
  • 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: Make Usa Llc
Labeler Code: 80486
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: 10-22-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Kindfill 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

Active Ingredient(S)

Sodium Fluoride .45mg (11.8 mg flouride ion)

Purpose

Anti-cavity

Use

Aids in the prevention of dental cavities

Warnings

  • When using this product, if irritation or sensitivity occurs discontinue use.Keep out of the reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Otc - When Using

When using this product, if irritation or sensitivity occurs discontinue use.

Otc - Keep Out Of Reach Of Children

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Adults and children 6 years of age and older; chew one tablet until crushed, wet toothbrush, brush for 2 minutes. Spit out.Do not swallow the tablet.Children under 6 years of age should be supervised when using this product.

Other Information

Store at 25-30°C (68-77°F). Protect from excessive moisture.

Inactive Ingredients

Microcrystalline Cellulose, Sodium bicarbonate (Baking Soda), Silica, Sodium Lauryl Glutamate, Magnesium Stearate, Natural Mint Flavor, Menthol, Xanthan Gum, Stevia (Stevioside), Citric Acid

* Please review the disclaimer below.