NDC 72164-102 Mini Duo

Potassium Nitrate, Sodium Fluoride

NDC Product Code 72164-102

NDC 72164-102-23

Package Description: 1 KIT in 1 KIT * 23 g in 1 TUBE (72164-001-02) * 23 g in 1 TUBE (72164-000-02)

NDC Product Information

Mini Duo with NDC 72164-102 is a a human over the counter drug product labeled by Smiletwice, Inc.. The generic name of Mini Duo is potassium nitrate, sodium fluoride. The product's dosage form is kit and is administered via form.

Labeler Name: Smiletwice, Inc.

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • XYLITOL (UNII: VCQ006KQ1E)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Labeler Information

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

Labeler Name: Smiletwice, Inc.
Labeler Code: 72164
FDA Application Number: part355B 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: 03-01-2020 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.

Mini Duo 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 Ingredients

Potassium Nitrate 5%


Sodium Fluoride 0.240% (0.15% w/v fluoride ion)

Purpose

AntihypersensitivityAnticavity

Uses

  • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. Aids in prevention of dental cavities.

When Using This Product,

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Stop Use And Ask A Dentist

If the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Children under 12 years: consult a dentist or doctor.

Inactive Ingredients

Water, Hydrated Silica, Sorbitol, Glycerin, Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Sodium Acorbyl Phosphate (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.

* Please review the disclaimer below.