NDC 71619-230 Miracletox Time Rewind Beyond Feel

Niacinamide, Adenosine

NDC Product Code 71619-230

NDC 71619-230-02

Package Description: 1 CONTAINER in 1 CARTON > 50 g in 1 CONTAINER (71619-230-01)

NDC Product Information

Miracletox Time Rewind Beyond Feel with NDC 71619-230 is a a human over the counter drug product labeled by Beauren Korea Inc.. The generic name of Miracletox Time Rewind Beyond Feel is niacinamide, adenosine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Beauren Korea Inc.

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.

Miracletox Time Rewind Beyond Feel 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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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 Feel Product Label Images

Miracletox Time Rewind Beyond Feel 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,Caprylic/Capric Triglyceride,Cetyl Ethylhexanoate,Butylene Glycol, Glyceryl Stearate,Glycerin,1,2-Hexanediol,Cetearyl Alcohol,Polysorbate 60,Butyrospermum Parkii (Shea) Butter,PEG-100 Stearate,Beeswax,Parfum,Methyl Trimethicone,Arginine,Carbomer,Ammonium Acryloyldimethyltaurate/VP Copolymer,Citric Acid,Prunus Armeniaca (Apricot) Kernel Oil,Limnanthes Alba (Meadowfoam) Seed Oil,Ceramide NS,Ceramide AS,Allantoin,Hydrolyzed Collagen,Ceramide EOP,Ceramide AP,Scutellaria Baicalensis Root Extract,Bletia Hyacinthina Bulb Extract,Coptis Japonica Root Extract,Rheum Palmatum Root Extract,Phellodendron Amurense Bark Extract,Tocopheryl Acetate,Dipotassium Glycyrrhizate,Paullinia Cupana Seed Extract,Annona Muricata Leaf/Stem Extract,Phyllanthus Emblica Fruit Extract,Disodium EDTA,Sodium PCA,Adansonia Digitata Seed Oil,Helichrysum Arenarium Extract,Centella Asiatica Extract,Pentylene Glycol,Hydrogenated Lecithin,Ceramide NP,Lavandula Angustifolia (Lavender) Extract,Rosmarinus Officinalis (Rosemary) Extract,Thymus Vulgaris (Thyme) Extract,Origanum Vulgare Flower/Leaf/Stem Extract,Sodium Hyaluronate,Copper Tripeptide-1,Asparagus Officinalis Extract,PPG-26-Buteth-26,PEG-40 Hydrogenated Castor Oil,Acetyl hexapeptide-8,Palmitoyl Tripeptide-5,Polycaprolactone,Hydrolyzed Hyaluronic Acid,Sodium hyaluronate Crosspolymer,Ethylhexylglycerin,Tripeptide-29,Hydrolyzed Sodium Hyaluronate,Hyaluronic Acid,Phosphatidylcholine,Caprylyl Glycol,Palmitoyl Tripeptide-1,sh-Polypeptide-69,Santalum Album (Sandalwood) Oil,Commiphora Myrrha Oil

Purpose

Purpose: Skin Brightening, Anti-wrinkle

Warnings

Warnings:For external use onlyAvoid contact with eyes.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 the cap sealed after every use. Do not put the contents back in the container once they are taken out because there is a possibility of deterioration.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:■ High nutrition premium cream with Peptide, Collagen, and Ceramide provides moisturizing, elasticity and vitality for the aging skin. Helps skin brightening and anti-wrinkle.

Directions

Directions:■ Apply a moderate amount on face and neck.

* Please review the disclaimer below.

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