NDC 70108-008 Shopkins Mouth Wash

Sodium Fluoride

NDC Product Code 70108-008

NDC CODE: 70108-008

Proprietary Name: Shopkins Mouth Wash 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 Fluoride 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.

Product Characteristics

RED (C48326 - FD & C RED 33)
RED (C48326 - FD &C RED 40)

NDC Code Structure

  • 70108 - Ashtel Studios Inc.

NDC 70108-008-01

Package Description: 479 g in 1 TUBE

NDC Product Information

Shopkins Mouth Wash with NDC 70108-008 is a a human over the counter drug product labeled by Ashtel Studios Inc.. The generic name of Shopkins Mouth Wash is sodium fluoride. The product's dosage form is liquid and is administered via dental form.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Shopkins Mouth Wash 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)

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: Ashtel Studios Inc.
Labeler Code: 70108
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: 10-06-2016 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 - 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.

Shopkins Mouth Wash Product Label Images

Shopkins Mouth Wash 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 - Purpose


Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental digestion seek professional assistance or contact a poison control center immediately.

Otc - Active Ingredient

Active Ingredient PurposeSodium Fluoride 0.5% (0.23% w/v fluoride ion) ......................... Anticavity

Indications & Usage

Helps protect teeth and roots against cavities


Keep out of reach of children.If you accidentally swallow seek medical help or contact a poison control center immediately

Inactive Ingredient

Water, Glycerine,PEG-40 Hydrogenated Castor Oil,Propylene Glycol,Xylitol,Benzyl Alcohol, Flavor, Sodium Benzoate, Sodium Saccharin, Zinc Gluconate, FD&C Red 40, D&C Red 33

Dosage & Administration

Adults and children 6 years and older:

Use daily after your normal brushing. Rinse toothpaste from your mouth prior to ouse.
Rinse or gargle for 30 seconds with 15ml (3 teaspoonful) and then spit it out.Do not swallow the mouth wash

* Please review the disclaimer below.