NDC 71141-161 Dentalux Kids Anticavity Fluoride Tooth Mixed Berry

Sodium Fluoride

NDC Product Code 71141-161

NDC 71141-161-32

Package Description: 126 g in 1 TUBE

NDC Product Information

Dentalux Kids Anticavity Fluoride Tooth Mixed Berry with NDC 71141-161 is a a human over the counter drug product labeled by Lidl Us, Llc. The generic name of Dentalux Kids Anticavity Fluoride Tooth Mixed Berry is sodium fluoride. The product's dosage form is paste and is administered via dental form.

Labeler Name: Lidl Us, 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.


Dentalux Kids Anticavity Fluoride Tooth Mixed Berry 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 .243 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)
  • SORBITOL (UNII: 506T60A25R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
  • MICA (UNII: V8A1AW0880)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • D&C RED NO. 28 (UNII: 767IP0Y5NH)

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: Lidl Us, Llc
Labeler Code: 71141
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: 04-24-2019 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: 12-31-2020 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’.

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Information for Patients

Fluoride

Fluoride is pronounced as (floor' ide)

Why is fluoride medication prescribed?
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usu...
[Read More]

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Dentalux Kids Anticavity Fluoride Tooth Mixed Berry Product Label Images

Dentalux Kids Anticavity Fluoride Tooth Mixed Berry 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

SODIUM FLUORIDE 0.243%(0.14% W/V FLUORIDE ION)

Purpose

ANTICAVITY

Use

HELPS PROTECT AGAINST CAVITIES

Warnings

Keep out of reach of children under 6 yrs. of age. 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.

Directions

  • Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or physician.Do not swallowTo minimize swallowing use a pea sized amount in children under 6Supervise children until good brushing and rinsing habits are established.For children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

Water, sorbitol, hydrated silica, propylene glycol, sodium C14-16 olefin sulfonate, xanthan gum, flavor, sodium saccharin, tocopheryl acetate, sodium methylparaben, mica, titanium dioxide, D&C Red No. 28

Questions?

1-844-656-5151www.lidl.com

* Please review the disclaimer below.

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