NDC 81647-040 Arocell Time Reverse K I T

Niacinamide

NDC Product Code 81647-040

NDC CODE: 81647-040

Proprietary Name: Arocell Time Reverse K I T 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

  • 81647 - Ficc Co., Ltd.

NDC 81647-040-01

Package Description: 1 KIT in 1 CARTON * 70 mL in 1 CONTAINER * .3 g in 1 CONTAINER

NDC Product Information

Arocell Time Reverse K I T with NDC 81647-040 is a a human over the counter drug product labeled by Ficc Co., Ltd.. The generic name of Arocell Time Reverse K I T is niacinamide. The product's dosage form is kit and is administered via form.

Labeler Name: Ficc Co., Ltd.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • ADENOSINE (UNII: K72T3FS567)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ficc Co., Ltd.
Labeler Code: 81647
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.

Arocell Time Reverse K I T Product Label Images

Arocell Time Reverse K I T 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 Ingredients

[AROCELL POWER ACTIVATOR]NIACINAMIDE 2.0%ADENOSINE 0.04%[AROCELL POWER CELL]NIACINAMIDE 10.0%

Inactive Ingredients

[AROCELL POWER ACTIVATOR]Water, Glycerin, Butylene Glycol, Propanediol, 1,2-Hexanediol, Polyglyceryl-10 Laurate, Ammonium Acryloyldimethyltaurate/VP, Sodium Hyaluronate, Human Cord Blood Cell Conditioned Media, Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Fragrance, Glycyrrhiza Glabra (Licorice) Root Extract, Agrimonia Eupatoria Extract, Disodium EDTA, Perilla Frutescens Leaf Extract, Silybum Marianum Seed Extract, Broussonetia Kazinoki Root Extract, Propolis Extract, Cimicifuga Dahurica Root Extract, Salix Alba (Willow) Bark Extract, Oenothera Biennis (Evening Primrose) Flower[AROCELL POWER CELL]Water, Human Cord Blood Cell Conditioned Media, Sodium Hyaluronate, Betaine, Ascorbic Acid, Trehalose, 1,2-Hexanediol, Hydrolyzed Collagen

Purpose

[AROCELL POWER ACTIVATOR]Skin BrighteningAnti wrinkle[AROCELL POWER CELL]Skin Brightening

Warnings

For external use onlyConsult a specialist if there are abnormal symptoms or side effects such as redness, swelling or itchiness due to direct sunlight during or after use.Avoid using on wounded areas.Keep out of reach of children

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

[AROCELL POWER ACTIVATOR]■ Helps brighten skin tone■ Helps improve wrinkle problem[AROCELL POWER CELL]■ Helps brighten skin tone

Directions

■ Take one Power Cell and open the cap by using the silver cylinder opener.■ Pour Power Activator into the Power Cell up to the mark on the side of Power Cell.■ Put on the white rubber cap onto the Power Cell and shake until the concentration dissolves.■ Apply adequate amount on skin and gently massage for full absorption.■ After use, put white rubber cap back. Use remaining ampoule within 7 days.

Other Information

■ Keep away from direct sunlight.

* Please review the disclaimer below.