NDC 71619-240 Miracletox Time Rewind Beyond Mask

Niacinamide, Adenosine

NDC Product Code 71619-240

NDC 71619-240-02

Package Description: 4 POUCH in 1 CARTON > 30 g in 1 POUCH (71619-240-01)

NDC Product Information

Miracletox Time Rewind Beyond Mask with NDC 71619-240 is a a human over the counter drug product labeled by Beauren Korea Inc.. The generic name of Miracletox Time Rewind Beyond Mask is niacinamide, adenosine. The product's dosage form is patch and is administered via topical form.

Labeler Name: Beauren Korea Inc.

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.

Miracletox Time Rewind Beyond 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 .6 g/30g
  • ADENOSINE .012 g/30g

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)
  • CETYL ETHYLHEXANOATE (UNII: 134647WMX4)

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: Beauren Korea Inc.
Labeler Code: 71619
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: 03-01-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Miracletox Time Rewind Beyond Mask Product Label Images

Miracletox Time Rewind Beyond 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,Cetyl Ethylhexanoate,1,2-Hexanediol,Butylene Glycol,Glycerin,Glyceryl Stearate,PEG-100 Stearate,Polysorbate 60,Betaine,Ammonium Acryloyldimethyltaurate/VP Cop,Helianthus Annuus (Sunflower) Seed Oil,Triticum Vulgare (Wheat) Germ Oil,Stearic Acid,Adansonia Digitata Seed Oil,Simmondsia Chinensis (Jojoba) Seed Oil,Limnanthes Alba (Meadowfoam) Seed Oil,Squalane,Portulaca Oleracea Extract,Hydrolyzed Collagen,Xanthan Gum,Disodium EDTA,Annona Muricata Leaf/Stem Extract,Phyllanthus Emblica Fruit Extract,Paullinia Cupana Seed Extract,Parfum,Vegetable Oil,Tocopheryl Acetate,Caprylic/Capric Triglyceride,Saccharomyces/Viscum Album (Mistletoe) Fe,Helichrysum Italicum Extract,Hydrogenated Lecithin,Scutellaria Baicalensis Root Extract,Bletilla Striata Root Extract,Coptis Japonica Root Extract,Rheum Palmatum Root Extract,Phellodendron Amurense Bark Extract,Lactobacillus/Soybean Ferment Extract,Ceramide NP,Saccharomyces/Imperata Cylindrica Root Ferment Extract,Lavandula Angustifolia (Lavender) Extract,Rosmarinus Officinalis (Rosemary) Extract,Thymus Vulgaris (Thyme) Extract,Origanum Vulgare Flower/Leaf/Stem Extract,Sodium Hyaluronate,Butyrospermum Parkii (Shea) Butter,Ceramide NS,Ceramide AS,Polycaprolactone,Cyclopentasiloxane,Tocopherol,Ethylhexylglycerin,Lecithin,Alcohol,Phosphatidylcholine,Ceramide EOP,Ceramide AP,PEG-40 Hydrogenated Castor Oil,PPG-26-Buteth-26,Caprylyl Glycol,Palmitoyl Tripeptide-1,Copper Tripeptide-1,Tripeptide-29,Acetyl hexapeptide-8,Palmitoyl Pentapeptide-4,sh-Polypeptide-69

Purpose

Purpose: Skin Brightening, Anti-wrinkle

Warnings

Warnings:For external use onlyAvoid contact with eyes.Use each mask (30g) only once.Discontinue use and consult a dermatologist if signs of red spot, irritation or rashes appear.Do not use on damaged or irritated skin. Do not apply to the areas of skin with wounds, eczema or any other preconditions.Do not use in case of allergy to any of the ingredients.Store away from high or low temperature, direct sunlight and high humidity.Keep out of reach of children. Not intended for use by children.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:■ A premium micro-fiber sheet mask with Peptide and Collagen provides moisturizing and vitality for the skin. Helps skin brightening and anti-wrinkle.

Directions

Directions:1. Take out the mask and unfold the folded parts.2. Apply the sheet mask adjusting around the eye and mouth.3. Leave on for 20~30 minutes. Remove mask and gently rub in remaining essence until fully absorbed. +Use the remaining essence on your neck and body as needed.

* Please review the disclaimer below.

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