NDC 72025-004 Close Up Travel

Sodium Fluoride

NDC Product Code 72025-004

NDC 72025-004-01

Package Description: 79 g in 1 TUBE

NDC Product Information

Close Up Travel with NDC 72025-004 is a a human over the counter drug product labeled by Jhs Svendgaard Laboratories Limited. The generic name of Close Up Travel is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1099038.

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.

Close Up Travel 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.


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)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • ALPHA CELLULOSE (UNII: I355QGZ19A)
  • SODIUM SILICATE (UNII: IJF18F77L3)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • PEG-32 LAURATE (UNII: F8XJF81O0F)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • ZINC SULFATE (UNII: 89DS0H96TB)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MELALEUCA ALTERNIFOLIA WHOLE (UNII: 976KV4FXYF)
  • EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3)
  • EUGENOL (UNII: 3T8H1794QW)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Jhs Svendgaard Laboratories Limited
Labeler Code: 72025
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: 12-27-2021 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.

Close Up Travel Product Label Images

Close Up Travel 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 Fluoride 0.21%

Otc - Purpose

Purpose:Anticavity

Indications & Usage

Uses:Aids in the prevention of dental cavities

Warnings

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age

Dosage & Administration

  • Directions:Do not swallow.Adults and children 2 years and older:Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • Children under 6 Years of AgeUse only a pea-sized amount and supervise children's brushing and rinsing to minimize swallowing.
  • Children under 2 years of age:Ask a dentist or physician

Inactive Ingredient

Inactive Ingredients:Sorbitor, Water, Silica, Sodium Lauryl Suphate, PEG-32, Titanium Dioxide, Flavor, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Zinc Sulfate, Sodium Hydroxide, D&C Red 33, FD&C Red 40, Synthetic Fluorphlogopite, Melaleuca Alternifolia (Tea Tree Extract), Eucalyptus Globulus (Eucalyptus Extract), Eugenol

* Please review the disclaimer below.