NDC 72193-004 The Saffron

Niacinamide, Adenosine

NDC Product Code 72193-004

NDC CODE: 72193-004

Proprietary Name: The Saffron 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

  • 72193 - Weekly Point Cosmetic

NDC 72193-004-02

Package Description: 10 PATCH in 1 CARTON > 27 g in 1 PATCH (72193-004-01)

NDC Product Information

The Saffron with NDC 72193-004 is a a human over the counter drug product labeled by Weekly Point Cosmetic. The generic name of The Saffron is niacinamide, adenosine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Weekly Point Cosmetic

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 Saffron 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 .594 g/27g
  • ADENOSINE .01296 g/27g

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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERETH-26 (UNII: NNE56F2N14)
  • ALCOHOL (UNII: 3K9958V90M)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • ARGININE (UNII: 94ZLA3W45F)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • BETAINE (UNII: 3SCV180C9W)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • GINGER (UNII: C5529G5JPQ)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

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: Weekly Point Cosmetic
Labeler Code: 72193
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: 03-02-2020 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 Saffron Product Label Images

The Saffron 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 2.2%Adenosine 0.048%

Otc - Purpose

BrightnessWrinkle Care

Indications & Usage

Helps to improve skin brightness and wrinkle care

Dosage & Administration

1. Clarify the skin tone with a skin


2. Spread the mask evenly on your face.


3. Apply it carefully on your face, and then leave for 15-20 minutes.


4. Take off the mask, if some contents are left on your skin, gently massage it for complete absorption. Folly up with your usual makeup.

Warnings

For external use only


Do not use on damaged or broken skin


Stop using and ask a doctor if rash occurs


When using this product, keep out of eyes. Rinse with water to remove

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Inactive Ingredient

Water, Glycereth-26, Glycerin, Butylene Glycol, Propanediol, Alcohol, 1,2-Hexanediol, Sorbitol,, Carbomer, Arginine, Hydroxyethylcellulose, Betaine, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Coptis Chinensis Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Camellia Sinensis Leaf Extract, Ethylhexylglycerin, Xanthan Gum, Dipropylene Glycol, Dipotassium Glycyrrhizate, Disodium EDTA, Polyglyceryl-10 Myristate, Polyglyceryl-10 Laurate, Fragrance, Sodium Hyaluronate, Crocus Sativus Flower Extract, Polysorbate 60, Sorbitan Isostearate

* Please review the disclaimer below.