NDC 71006-040 Rubelli Black Pearl Mask

Niacinamide, Adenosine

NDC Product Code 71006-040

NDC 71006-040-02

Package Description: 4 POUCH in 1 CARTON > 25 mL in 1 POUCH (71006-040-01)

NDC Product Information

Rubelli Black Pearl Mask with NDC 71006-040 is a a human over the counter drug product labeled by Rubelli Co.,ltd. The generic name of Rubelli Black Pearl Mask is niacinamide, adenosine. The product's dosage form is patch and is administered via topical form.

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.

Rubelli Black Pearl 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.


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)

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: Rubelli Co.,ltd
Labeler Code: 71006
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: 06-01-2017 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 - 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.

Rubelli Black Pearl Mask Product Label Images

Rubelli Black Pearl 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 Ingredient

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

Inactive Ingredient

Inactive ingredients: Water, Glycerin, Butylene Glycol, Diglycerin, 1,2-Hexanediol, Betaine, Erythritol, Xylitol, Panthenol, Pearl powder(100ppm), Centella Asiatica Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita(Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Punica Granatum Fruit Extract, Ficus Carica (Fig) Fruit Extract, Morus Alba Fruit Extract, Ginkgo Biloba Nut Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, PEG-40 Hydrogenated Castor Oil, Dipotassium Glycyrrhizate, Fragrance, Xanthan Gum, Potassium Hydroxide

Purpose

Purpose: Skin Brightening & Anti wrinkle

Warnings

Warnings: For external use only 1. Please consult with a physician or other qualified health provider if you have abnormal symptoms such as red spot, swelling or itching, or side effects caused by exposure to direct sunlight, during or after use of the product,. 2. Avoid areas with wounds or other sensitive areas 3. Precautions for storage and handling Keep out of reach of children. Avoid direct exposure to sunlight. Avoid contact with eyes.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

Uses: Black Pearl Mask, the high functional mask containing black pearl from Tahiti, French Polynesia, provides rich nourishment to the skin. The two patented ingredients, BSASM™ and Oriental Beauty Fruits Newplex, helps bring vitality and healthiness to the skin. Also, niacinamide and adenosine ingredients contained in this dual functional mask are helpful for skin brightening and improving wrinkles.

Directions

Directions: 1. Remove moisture after facial washing and arrange the skin texture using cosmetic water. 2. Open the pouch and take out the sheet, and tightly adhere to the skin following the facial shape. 3. Remove the sheet after 15~20 minutes and tap gently in order to get the remaining essence absorbed.

* Please review the disclaimer below.