NDC 81647-010 Arocell Moisturizing

Niacinamide, Adenosine

NDC Product Code 81647-010

NDC 81647-010-02

Package Description: 1 CONTAINER in 1 CARTON > 50 g in 1 CONTAINER (81647-010-01)

NDC Product Information

Arocell Moisturizing with NDC 81647-010 is a a human over the counter drug product labeled by Ficc Co., Ltd.. The generic name of Arocell Moisturizing is niacinamide, adenosine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Ficc 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.

Arocell Moisturizing 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 1 g/50g
  • ADENOSINE .02 g/50g

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)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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: 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 Moisturizing Product Label Images

Arocell Moisturizing 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

NIACINAMIDE 2.0%ADENOSINE 0.04%

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Caprylic/Capric/Succinic Triglyceride, Butylene Glycol, Propanediol, Cyclohexasiloxane, Cetearyl Olivate, Dicaprylyl Carbonate, Cetearyl Alcohol, 1,2-Hexanediol, Sorbitan Olivate, Butyrospermum Parkii (Shea) Butter, Donkey Milk, Glyceryl Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Carbomer, Tromethamine, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Human Cord Blood Cell Conditioned Media, Xanthan Gum, Palmitic Acid, Ethylhexylglycerin, Stearic Acid, Disodium EDTA, Salvia Officinalis (Sage) Oil, Dipotassium Glycyrrhizate, Panthenol, Tranexamic Acid, Hydrolyzed Jojoba Esters, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Agrimonia Eupatoria Extract, Biosaccharide Gum-1, Centella Asiatica Extract, Houttuynia Cordata Extract, Perilla Frutescens Leaf Extract, Salvia Hispanica Seed Extract, Silybum Marianum Seed Extract, Sodium Hyaluronate, Beta-Glucan, Broussonetia Kazinoki Root Extract, Propolis Extract, Cimicifuga Dahurica Root Extract, Salix Alba (Willow) Bark Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Limonene, Linalool

Purpose

Skin BrighteningAnti-wrinkle

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

■ Helps brighten skin tone■ Helps improve wrinkle problem

Directions

■ Apply an appropriate amount and massage gently into skin at the last stage of skin care routine.

Other Information

■ Keep away from direct sunlight.

* Please review the disclaimer below.