NDC 78417-010 The Fact-sfn Brightening Anti-wrinkle

Niacinamide, Adenosine

NDC Product Code 78417-010

NDC 78417-010-01

Package Description: 50 mL in 1 JAR

NDC Product Information

The Fact-sfn Brightening Anti-wrinkle with NDC 78417-010 is a a human over the counter drug product labeled by Yegreena Co., Ltd.. The generic name of The Fact-sfn Brightening Anti-wrinkle is niacinamide, adenosine. 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.

The Fact-sfn Brightening Anti-wrinkle 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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALLANTOIN (UNII: 344S277G0Z)
  • CAMELLIA JAPONICA FLOWER (UNII: KUB8101TNF)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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: Yegreena Co., Ltd.
Labeler Code: 78417
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: 11-02-2021 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: 12-31-2022 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.

The Fact-sfn Brightening Anti-wrinkle Product Label Images

The Fact-sfn Brightening Anti-wrinkle 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

Niacinamide, Adenosine

Otc - Purpose

Whitening, treating wrinkles, and skin balance

Indications & Usage

After applying a toner or lotion in the morning or evening, gently apply on face and neck area while avoiding the eyes and lips. Especially recommended for use after a round of going through the golf course, in order to maintain the skin balance.

Warnings

1) Please consult your doctor if you experience side effects such as swelling, itching, or reddening on the area where you applied the cream.2) Do not apply on wounds or cuts.3) Do not store where children may reach, and avoid keeping it exposed to direct sunlight.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

For external use only.

Inactive Ingredient

Water, Butylene Glycol, Glycerin, Dimethicone, Alcohol, Oleth-5, Bis-PEG-18 Methyl Ether Dimethyl Silane, Ammonium cryloyldimethyltaurate/VP Copolymer, Silica, Hydrogenated Lecithin, Sorbitol, Brassica Oleracea Italica (Broccoli) Extract, Trehalose, 1,2-Hexanediol, Caprylyl Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Carbomer, Tromethamine, Fragrance, Allantoin, Synthetic Fluorphlogopite, Disodium EDTA, Tocopheryl Acetate, Acacia Senegal Gum, Caffeine, CI 77891, Illicium Verum (Anise) Fruit Extract, Sodium Hyaluronate, Peat Water, Citric Acid, Hydroxypropyl Methylcellulose, Mica, BHT, Scutellaria Baicalensis Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Sesamum Indicum (Sesame) Seed Extract, Polygonum Multiflorum Root Extract, Phellinus Linteus Extract, Sophora lavescens Root Extract, Cimicifuga Racemosa Root Extract, Morus Alba Bark Extract, Angelica Gigas Root Extract, Paeonia actiflora Root Extract, Sigesbeckia Orientalis Extract, Potassium Sorbate, Dipeptide Diaminobutyroyl Benzylamide Diacetate, Triethoxycaprylylsilane, Camellia Sinensis Leaf Extract, Ethylhexylglycerin, Nymphaea Alba Flower Extract, Camellia Japonica Flower Extract, Prunus Serrulata Flower Extract, Nelumbium Speciosum Flower Extract, Rosa Hybrid Flower Extract, Copper Tripeptide-1, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4, Tripeptide-1, Palmitoyl Tripeptide-1, Hexapeptide-9, Nonapeptide-1, Limonene

* Please review the disclaimer below.