NDC 70567-040 Grain Vita Fermented

Dimethicone

NDC Product Code 70567-040

NDC CODE: 70567-040

Proprietary Name: Grain Vita Fermented 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 (including 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

  • 70567 - Khleekorea

NDC 70567-040-01

Package Description: 50 mL in 1 CARTON

NDC Product Information

Grain Vita Fermented with NDC 70567-040 is a a human over the counter drug product labeled by Khleekorea. The generic name of Grain Vita Fermented is dimethicone. The product's dosage form is cream and is administered via topical form.

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.

Grain Vita Fermented 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)
  • 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: Khleekorea
Labeler Code: 70567
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: 03-02-2016 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.

Grain Vita Fermented Product Label Images

Grain Vita Fermented 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 2.0%

Inactive Ingredient

Inactive Ingredients: Water, Glycerin, Butylene Glycol, Caprylic/Capric Triglyceride, Polysorbate 60, Beeswax, Cetearyl Alcohol, Glyceryl Stearate SE, Butyrospermum Parkii (Shea) Butter, Sodium Hyaluronate, Sorbitan Sesquioleate, Betula Alba Juice, Betaine, Copernicia Cerifera (Carnauba) Wax, Adenosine, Saccharomyces/Rice Bran Ferment, Tocopheryl Acetate, Oryza Sativa (Rice) Extract, Sesamum Indicum (Sesame) Seed Extract, Perilla Ocymoides Seed Extract, Phaseolus Radiatus Seed Extract, Triticum Turgidum Durum (Wheat) Seed Extract, Phaseolus Angularis Seed Extract, Glycine Max (Soybean) Seed Extract, Pinus Koraiensis Seed Extract, Glycine Max (Soybean) Seed Extract, Juglans Regia (Walnut) Seed Extract, Arachis Hypogaea (Peanut) Fruit Extract, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Sesamum Indicum (Sesame) Seed Extract, Polygonum Fagopyrum (Buckwheat) Seed Extract, Coix Lacryma-Jobi Ma-yuen Seed Extract, Hordeum Distichon (Barley) Extract, Helianthus Annuus (Sunflower) Seed Extract, Avena Sativa (Oat) Meal Extract, Rosa Canina Seed Extract, Ginkgo Biloba Nut Extract, Honey Extract, Wild Ginseng Root Culture Extract, Chrysanthemum Morifolium Flower Extract, Citrus Unshiu Fruit Extract, Oenothera Biennis (Evening Primrose) Oil, Phellodendron Amurense Bark Extract, Coptis Chinensis Root Extract, Scutellaria Baicalensis Root Extract, Rhus Semialata Gall Extract, Silkworm Extract, Allantoin, 1,2-Hexanediol, Carbomer, Disodium EDTA, Triethanolamine, Phenoxyethanol, Fragrance

Purpose

Purpose: Anti-wrinkleCompounding the substances from Saccharomyces/Rice Bran Ferment and Tocopheryl Acetate, vitamin E derivative, on the base of grain extracts make the skin comfortable, it firmly protects the moisture to smooth the skin and gives the anti-wrinkle function. Grain based moisturizing ingredients. Skin conditioning component ( vitamin E derivative ) compounding. Firmly to protect the moisture of skin , to smooth skin. Anti-wrinkle functional cream.

Warnings

Warnings: 1. If the following symptoms arise upon use of the cosmetic product, immediately discontinue use and consult a dermatologist, for continued use may aggravate the symptoms. A. Redness, swelling, itchiness, stimulation, or other symptoms B. Occurrence of the above symptoms upon exposure to direct sunlight. 2. Do not use on areas with wounds, eczema, or dermatitis. 3. Do not store in areas with extreme heat or cold, or under direct sunlight. 4. Avoid the eye area 5. Keep out of reach of children

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Indications & Usage

Indications & Usage: Softly apply cream along the skin texture and pat gently for better absorption. 1. Put size of a nickel on the palm and apply to entire face and neck evenly. 2. Apply to the face outwards and neck from tap-down.

Dosage & Administration

Dosage & Administration: Take an adequate amount of this product.

* Please review the disclaimer below.