NDC 81418-080 Cosmepure Brightening Calming Toner

Niacinamide

NDC Product Code 81418-080

NDC CODE: 81418-080

Proprietary Name: Cosmepure Brightening Calming Toner 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

  • 81418 - Cosmogen Co., Ltd.
    • 81418-080 - Cosmepure Brightening Calming Toner

NDC 81418-080-02

Package Description: 1 BOTTLE in 1 CARTON > 130 mL in 1 BOTTLE (81418-080-01)

NDC Product Information

Cosmepure Brightening Calming Toner with NDC 81418-080 is a a human over the counter drug product labeled by Cosmogen Co., Ltd.. The generic name of Cosmepure Brightening Calming Toner is niacinamide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Cosmogen 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.

Cosmepure Brightening Calming Toner 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 2.6 g/130mL

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)
  • REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
  • 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: Cosmogen Co., Ltd.
Labeler Code: 81418
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: 03-01-2021 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.

Cosmepure Brightening Calming Toner Product Label Images

Cosmepure Brightening Calming Toner 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

Niacinamide 2.0%

Inactive Ingredients

Water, Polygonum Multiflorum Root Extract, Glycerin, Betaine, Butylene Glycol, 1,2-Hexanediol, Hyaluronic Acid, Calendula Officinalis Flower Extract, Aloe Barbadensis Leaf Extract, Salicornia Herbacea Extract, Salix Nigra (Willow) Bark Extract, Lavandula Angustifolia (Lavender) Flower Water, Houttuynia Cordata Extract, allantoin, PEG-60 Hydrogenated castor oil, Carbomer, Disodium EDTA, Potassium hydroxide, Fragrance

Purpose

Skin brightening

Warnings

For external use onlyAvoid contact with eyes.Discontinue use if signs of irritation or rashes appear.Replace the cap after use.Keep out of reach of children

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps improve trouble relax and good for sensitive skin

Directions

■ Apply an appropriate amount evenly on the skin.

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Questions

■ www.cosmepure.kr

* Please review the disclaimer below.