NDC 72289-0007 Tals Cellular Rejuvenating Moisture Eye

Glycerin

NDC Product Code 72289-0007

NDC Code: 72289-0007

Proprietary Name: Tals Cellular Rejuvenating Moisture Eye Additional informationCallout TooltipWhat 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: Glycerin Additional informationCallout TooltipWhat 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.


Code Structure
  • 72289 - Skincure Inc
    • 72289-0007 - Tals Cellular Rejuvenating Moisture Eye

NDC 72289-0007-1

Package Description: 30 mL in 1 TUBE

NDC Product Information

Tals Cellular Rejuvenating Moisture Eye with NDC 72289-0007 is a a human over the counter drug product labeled by Skincure Inc. The generic name of Tals Cellular Rejuvenating Moisture Eye is glycerin. The product's dosage form is cream and is administered via topical form.

Labeler Name: Skincure Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Tals Cellular Rejuvenating Moisture Eye Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GLYCERIN 3 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • PANTHENOL (UNII: WV9CM0O67Z)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Skincure Inc
Labeler Code: 72289
FDA Application Number: part347 Additional informationCallout TooltipWhat 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. Additional informationCallout TooltipWhat 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: 02-24-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Tals Cellular Rejuvenating Moisture Eye Product Label Images

Tals Cellular Rejuvenating Moisture Eye 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

Glycerin

Inactive Ingredient

Camellia Japonica Flower Extract

Water(Aqua)

Caprylic/Capric Triglyceride

Glycerin

Pentylene Glycol

Propanediol

Camellia Japonica Seed Oil

Niacinamide

Hydrogenated Palm Kernel Oil

Phosphatidylcholine

Phytosteryl Macadamiate

Butyrospermum Parkii (Shea) Butter

Mangifera Indica (Mango) Seed Butter

Arginine

Xanthan Gum

Cetearyl Olivate

Camellia Sinensis Leaf Extract

Chamomilla Recutita (Matricaria) Leaf Extract

Thujopsis Dolabrata Branch Extract

Panthenol

Sorbitan Olivate

Sorbitan Caprylate

Asiaticoside

Magnolia Kobus Bark Extract

Salix Alba (Willow) Bark Extract

Squalane

Trehalose

Adenosine

Polygonum Cuspidatum Root Extract

Aloe Barbadensis Leaf Extract

Angelica Gigas Extract

Aspartic Acid

Cimicifuga Racemosa Root Extract

Equisetum Hiemale Extract

Pueraria Lobata Root Extract

Punica Granatum Fruit Extract

Soy Isoflavones

Trifolium Pratense (Clover) Flower Extract

Hizikia Fusiforme Extract

Yeast Beta-Glucan

Levulinic Acid

Bioflavonoids

Hyaluronic Acid

Brassica Oleracea Italica (Broccoli) Extract

Michelia Alba Flower Oil

Rose Flower Oil

Cananga Odorata Flower Oil

Otc - Purpose

This rejuvenating eye cream helps minimize the ravages of time and diminish discoloration and unevenness around the eyesvisibly reduces the appreaance of fine lines and wrinkles

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Spread a thin layer onto entire eye area and gently dab around the eyes. For the best results, use twice a day morning and night.

Warnings

For external use onlydo not use if sensitive to any of the ingredientsdiscontinue use if signs of irritation or rash appearif irritation or rash persists, contact a doctor

Dosage & Administration

For external use only

* Please review the disclaimer below.

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