NDC 52000-112 Universal Advanced Whitening Anti-cavity Fluoride

Sodium Monofluorophosphate

NDC Product Code 52000-112

NDC CODE: 52000-112

Proprietary Name: Universal Advanced Whitening Anti-cavity Fluoride 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: Sodium Monofluorophosphate 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.

NDC Code Structure

  • 52000 - Universal Distribution Center Llc
    • 52000-112 - Universal Advanced Whitening Anti-cavity Fluoride

NDC 52000-112-01

Package Description: 181 g in 1 TUBE

NDC Product Information

Universal Advanced Whitening Anti-cavity Fluoride with NDC 52000-112 is a a human over the counter drug product labeled by Universal Distribution Center Llc. The generic name of Universal Advanced Whitening Anti-cavity Fluoride is sodium monofluorophosphate. The product's dosage form is paste and is administered via dental form.

Labeler Name: Universal Distribution Center Llc

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Universal Advanced Whitening Anti-cavity Fluoride 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 MONOFLUOROPHOSPHATE .76 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.

  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SORBITOL (UNII: 506T60A25R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: Universal Distribution Center Llc
Labeler Code: 52000
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: 05-30-2020 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.

Universal Advanced Whitening Anti-cavity Fluoride Product Label Images

Universal Advanced Whitening Anti-cavity Fluoride 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

Otc - Active Ingredient

Active IngredientSodium Monofluorophosphate  0.76% (1000 ppm)

Otc - Purpose

PurposeAnticavity toothpaste

Indications & Usage

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

Warnings

Warning

Otc - When Using

  • When using this productif pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.

Otc - Stop Use

  • Stop and ask a dentistif the problem persists or worsens.Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of childrenIf accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Dosage & Administration

  • Directionsadults and children of 2 years and older: brush teeth thoroughly after meals or at least twice a day, or as directed by a dentist.do not swallow.to minimize swallowing, use a pea-sized amount in children under 6 years old.supervise children's brushing until good habits are established.children under 2 years: ask a dentist before use.Children under 12 years of age: Consult a dentist or doctor

Other

  • Other informationstore in a cool, dry place.

Inactive Ingredient

Inactive IngredientsCalcium carbonate, Water, Glycerine, Silica, Sodium Lauryl sulphate, Sorbitol, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium carboxy methyl cellulose, Flavor and FD&C blue #1

* Please review the disclaimer below.