NDC 73494-010 Divinetree Ssak Shark Kids Tooth

Silicon Dioxide, Alcloxa

NDC Product Code 73494-010

NDC 73494-010-02

Package Description: 1 TUBE in 1 CARTON > 50 g in 1 TUBE (73494-010-01)

NDC Product Information

Divinetree Ssak Shark Kids Tooth with NDC 73494-010 is a a human over the counter drug product labeled by K.biocos. The generic name of Divinetree Ssak Shark Kids Tooth is silicon dioxide, alcloxa. The product's dosage form is paste, dentifrice and is administered via oral form.

Labeler Name: K.biocos

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.

Divinetree Ssak Shark Kids Tooth 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.

  • SILICON DIOXIDE 6.5 g/50g
  • ALCLOXA .08 g/50g

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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL (UNII: 506T60A25R)

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.
  • 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: K.biocos
Labeler Code: 73494
Marketing Category: UNAPPROVED DRUG OTHER - 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: 11-01-2019 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’.

* Please review the disclaimer below.

Divinetree Ssak Shark Kids Tooth Product Label Images

Divinetree Ssak Shark Kids Tooth 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

Active Ingredient: Silica 13.0%, Alcloxa 0.16%

Inactive Ingredient

Inactive Ingredients: Glycerin, Sorbitol, Cellulose Gum, Xylitol, Ascorbic Acid, Stevioside, Glycyrrhiza Glabra (Licorice) Root Extract, Salvia Officinalis (Sage) Leaf Extract, Calcium Glycerophosphate, Milk, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Calendula Officinalis Flower Extract, Streptococcus Thermophilus Ferment, Chamomilla Recutita (Matricaria) Flower Extract, Chamaecyparis Obtusa Oil, Eucalyptus Globulus Leaf Oil, Flavor, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate, Water

Purpose

Purpose: Anticavities, Anticarries

Warnings

Warnings: Keep out of the reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep Out Of Reach Of Children

Keep out of the reach of children under 6 years of age.

Uses

Uses:Brightens and Strengthens teethLeaves the mouth clean and freshProtects against gingivitis and paradentitisProtects against gum diseaseRemoves Plaque

Directions

Directions:Recommended for ages 3years and olderApply a peas size amount on toothbrush and brush teeth thoroughly. Use at least twice a day preferably after each meal or as directed by a dentist or physician.Children should be supervised to minimize swallowing.

* Please review the disclaimer below.