NDC 81647-060 Arocell Super Power Mask

Niacinamide, Adenosine

NDC Product Code 81647-060

NDC 81647-060-02

Package Description: 4 PATCH in 1 CARTON > 42 g in 1 PATCH (81647-060-01)

NDC Product Information

Arocell Super Power Mask with NDC 81647-060 is a a human over the counter drug product labeled by Ficc Co., Ltd.. The generic name of Arocell Super Power Mask is niacinamide, adenosine. The product's dosage form is patch and is administered via topical form.

Labeler Name: Ficc Co., Ltd.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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 Super Power Mask 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 .84 g/42g
  • ADENOSINE .01 g/42g

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)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)

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 Super Power Mask Product Label Images

Arocell Super Power Mask 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, Dipropylene Glycol, Cetyl Ethylhexanoate, Ceratonia Siliqua (Carob) Gum, Chondrus Crispus Extract, Hydrolyzed Collagen, Hydroxyacetophenone, Betaine, Trehalose, Panthenol, Butyrospermum Parkii (Shea) Butter, Cellulose Gum, Glyceryl Stearate, PEG-100 Stearate, Sodium polyacrylate, Polysorbate 60, Potassium Chloride, Sucrose, Hydrogenated Polydecene, Disodium EDTA, Ethylhexylglycerin, Theobroma Cacao (Cocoa) Seed Extract, Fragrance, 1,2-Hexanediol, Trideceth-6, Lecithin, Human Cord Blood Cell Conditioned Media (30ppm), Hydrogenated Lecithin, Sodium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Tocopherol, Cholesterol, Sodium Acetylated Hyaluronate, Hydrolyzed Hyaluronic Acid, Palmitoyl Tripeptide-5, Leontopodium Alpinum Callus Culture Extract, Hyaluronic Acid, Sodium Hyaluronate Crosspolymer, Hydrolyzed Sodium Hyaluronate, Potassium Hyaluronate, Copper Tripeptide-1, Tripeptide-1, Palmitoyl Pentapeptide-4, Dipeptide-2, Oligopeptide-1

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

■ After cleansing, carefully treat your skin using your preferred toner.■ Open the package, remove the film from the lower half of the face mask and attach it around your lips.■ Remove the film from the upper half of the face mask and attach it around your eyes to adhere.■ After 30~40 minutes, remove the mask and gently massage the remaining essence on your skin for full absorption.■ For better results, apply for more than 3 hours. As the maximum dosage is 42g, it is recommended to use at least 3~5 hours until the translucent gel becomes transparent.

Other Information

■ Keep away from direct sunlight.■ Be careful as this product is prone to tear.■ After opening the pouch, use the product immediately as it may become dry.

* Please review the disclaimer below.