NDC 60565-020 Cellisys Ex Wrinkle Solution Eye Contour

Dimethicone

NDC Product Code 60565-020

NDC CODE: 60565-020

Proprietary Name: Cellisys Ex Wrinkle Solution Eye Contour 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: Dimethicone 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.

NDC Code Structure

  • 60565 - Dn Company Co., Ltd.
    • 60565-020 - Cellisys Ex Wrinkle Solution Eye Contour

NDC 60565-020-01

Package Description: 15 mL in 1 CARTON

NDC Product Information

Cellisys Ex Wrinkle Solution Eye Contour with NDC 60565-020 is a a human over the counter drug product labeled by Dn Company Co., Ltd.. The generic name of Cellisys Ex Wrinkle Solution Eye Contour is dimethicone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Dn Company Co., Ltd.

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 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.

Cellisys Ex Wrinkle Solution Eye Contour 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.

  • DIMETHICONE .51 mg/15mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

What 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

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

Labeler Name: Dn Company Co., Ltd.
Labeler Code: 60565
FDA Application Number: part347 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: 07-01-2013 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 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.

Cellisys Ex Wrinkle Solution Eye Contour Product Label Images

Cellisys Ex Wrinkle Solution Eye Contour 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: Dimethicone 1%

Inactive Ingredient

INACTIVE INGREDIENTS:Water, Glycerin, Cyclopentasiloxane, Mineral Oil, Cetearyl Alcohol, Hydrogenated Poly (C6-14 Olefin), Petrolatum, Macadamia Integrifolia Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Pseudoalteromonas Ferment Extract, Argania Spinosa Kernel Oil, Thermus Thermophillus Ferment, Sorbitan Stearate, PEG-40 Stearate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Trehalose, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Triethanolamine, Caprylic/Capric Triglyceride, Betaine, Ceramide 3, Sodium Polyacrylate, Tocopheryl Acetate, Hydrogenated Lecithin, Butylene Glycol, Phytosphingosine, Potassium Cetyl Phosphate, Sodium Hyaluronate, Sodium Ascorbyl Phosphate, Polysorbate 20, sh-Oligopeptide-1, Palmitoyl Oligopeptide, Palmitoyl Tripeptide-5, Palmitoyl Tetrapeptide-7, Adenosine, Stearyl Alcohol, Carbomer, Alcohol Denat., Xanthan Gum, BHT, Disodium EDTA, Phenoxyethanol, Methylparaben, Propylparaben, Fragrance (Parfum), Yellow 5 (CI 19140), Yellow 6 (CI 15985)

Purpose

PURPOSE: Skin protectant

Warnings

WARNING:For external use only.Avoid contact with eyes.Discontinue use if signs of irritation or rash appear.Keep out of reach of babies and children.

Keep Out Of Reach Of Children

Keep out of reach of babies and children.

Indications And Usage

INDICATION AND USAGE:Tighten the lid after using it.Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.

Dosage And Administration

DOSAGE AND ADMINISTRATION:After essence step or cream step, take an appropriate amount and apply to the area around eyes with patting thoroughly to let it absorb into the skin.

* Please review the disclaimer below.