NDC 77049-0002 The Fact Natural Spn18 - The Juniorcream

Niacinamide, Adenosine

NDC Product Code 77049-0002

NDC CODE: 77049-0002

Proprietary Name: The Fact Natural Spn18 - The Juniorcream 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: Niacinamide, Adenosine 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.

  • Niacinamide (nicotinamide) is a form of vitamin B3 (niacin) and is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacinamide is often used instead of niacin because it causes fewer side effects (e.g., flushing). Unlike niacin, niacinamide does not help correct blood fat levels and cannot be substituted for niacin if you are being treated for a blood fat problem (e.g., high cholesterol). Niacin deficiency may happen as a result of poor diet, certain medical conditions (e.g., alcohol abuse, malabsorption syndrome, Hartnup disease), or long-term use of certain medications (e.g., isoniazid). It is best to get your vitamins from healthy foods. A multivitamin may be recommended by your doctor instead of niacinamide because poor diet usually causes deficiencies in more than one vitamin. Vitamins help to support the body's ability to make and break down natural substances (metabolism) and are needed for good health.
  • Drug uses not available

NDC Code Structure

  • 77049 - Interkos Co.,ltd.
    • 77049-0002 - The Fact Natural Spn18 - The Juniorcream

NDC 77049-0002-1

Package Description: 30 mL in 1 CONTAINER

NDC Product Information

The Fact Natural Spn18 - The Juniorcream with NDC 77049-0002 is a a human over the counter drug product labeled by Interkos Co.,ltd.. The generic name of The Fact Natural Spn18 - The Juniorcream is niacinamide, adenosine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Interkos 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.

The Fact Natural Spn18 - The Juniorcream 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.

  • NIACINAMIDE 3 g/100mL
  • ADENOSINE .04 g/100mL

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.

  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • 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.
  • 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: Interkos Co.,ltd.
Labeler Code: 77049
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: 05-02-2020 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.

The Fact Natural Spn18 - The Juniorcream Product Label Images

The Fact Natural Spn18 - The Juniorcream 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

Inactive Ingredient

Water, butylene glycol, glycerin, dimethicone, cyclopentasiloxane, illicium verum(anise) fruit extract, allantoin, synthetic fluorphlogopite, disodium edta, tocopheryl acetate, alcohol, caffeine, titanuim dioxide, sodium hyaluronate, brassica oleracea italica (broccoli) extract, scutellaria baicalensis root extract, mica, bht, glycyrrhiza glabra (licorice) root extract, polygonum multiflorum root extract, phellinus linteus extract, morus alba bark extract, sophora flavescens root extract, sesamum indicum ( sesame) seed extract, angelica gigas root extract, sigesbeckia orientalis extract, paeonia lactiflora extract, cimicifuga racemosa root extract, peg-40 hydrogenated castor oil, dipeptide diaminobutyroyl benzylamide diacetate, ppg-26-buteth-26, triethoxycaprylylsilane, camellia sinensis leaf extract, ethylhexylglycerin, prunus serrulata flower extract, nymphaea alba flower extract, nelumbium speciosum flower extract, camellia japonica flower extract, rosa hybrid flower extract, palmitoyl tripeptide-1, tripeptide-1, copper tripeptide-1, acetyl hexapeptide-8, palmitoyl pentapeptide-4, hexapeptide-9, nonapeptide-1, oleth-5, bis-peg18 methyl ether dimethyl silane, silica, ammonium acryloyldimethyltaurate/vp copolymer, hydrogenated lecithin, sorbitol, trehalose, caprylyl glycol, dimethicone/vinyl dimethicone crosspolymer, carbomer, tromethamine, 1,2-hexanediol

Otc - Purpose

For skin protectant

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF THE CHILDREN

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.

Dosage & Administration

External use only

* Please review the disclaimer below.