NDC 62041-280 Cellexosome Sb

Niacinamide

NDC Product Code 62041-280

NDC CODE: 62041-280

Proprietary Name: Cellexosome Sb 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 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.

NDC Code Structure

  • 62041 - Prostemics Co., Ltd.

NDC 62041-280-02

Package Description: 5 CONTAINER in 1 CARTON > 3 mL in 1 CONTAINER (62041-280-01)

NDC Product Information

Cellexosome Sb with NDC 62041-280 is a a human over the counter drug product labeled by Prostemics Co., Ltd.. The generic name of Cellexosome Sb is niacinamide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Prostemics Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Cellexosome Sb 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 .09 g/3mL

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)
  • TRANEXAMIC ACID (UNII: 6T84R30KC1)

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: Prostemics Co., Ltd.
Labeler Code: 62041
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: 02-01-2020 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.

Cellexosome Sb Product Label Images

Cellexosome Sb 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 ingredients: Niacinamide 3.0%

Inactive Ingredient

Inactive ingredients:[Powder] HUMAN ADIPOSE DERIVED STEM CELL CONDITIONED MEDIA, Panax Ginseng Root Extract[Solvent] Water, Tranexamic Acid, Water, 1,2-Hexanediol, Hydroxyacetophenone, Ascorbyl Glucoside, Sodium Hyaluronate

Purpose

Purpose: Skin Brightening

Warnings

Warnings:For external use only1. Discontinue use if signs of irritation or rashes appear. If symptoms get worse, consult with a dermatologist. 1) In case of swelling, itching, or other side effects while or after using this product2. Do not apply to open wounds.3. Avoid contact with eyes.Storage and handling4. Replace the cap after use5. Keep out of reach of children.6. Avoid direct sunlight.

Keep Out Of Reach Of Children Section

KEEP OUT OF REACH OF CHILDREN SECTION

Uses

Uses:Helps brighten skin tone.

Directions

Directions:■ Put solvent into the powder ampoule and shake gently enough to dissolve the mixture■ Take proper amount and gently apply onto the skin

* Please review the disclaimer below.