NDC 71619-250 Miracletox Time Rewind Beyond Tox Ampoule

Niacinamide, Adenosine

NDC Product Code 71619-250

NDC Code: 71619-250

Proprietary Name: Miracletox Time Rewind Beyond Tox Ampoule What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Niacinamide, Adenosine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 71619 - Beauren Korea Inc.
    • 71619-250 - Miracletox Time Rewind Beyond Tox Ampoule

NDC 71619-250-02

Package Description: 4 VIAL in 1 CARTON > 2 g in 1 VIAL (71619-250-01)

NDC Product Information

Miracletox Time Rewind Beyond Tox Ampoule with NDC 71619-250 is a a human over the counter drug product labeled by Beauren Korea Inc.. The generic name of Miracletox Time Rewind Beyond Tox Ampoule is niacinamide, adenosine. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Beauren Korea Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 Tox Ampoule 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 .04 g/2g
  • ADENOSINE .0008 g/2g

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 Tox Ampoule Product Label Images

Miracletox Time Rewind Beyond Tox Ampoule 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,Butylene Glycol,Butylene Glycol Dicaprylate/Dicaprate,Hydrolyzed Sponge,Caprylic/Capric Triglyceride,Glycerin,Cetearyl Alcohol,Macadamia Ternifolia Seed Oil,1,2-Hexanediol,Simmondsia Chinensis (Jojoba) Seed Oil,Polyglutamic Acid,Beeswax,Butyrospermum Parkii (Shea) Butter,Dimethicone,Sorbitan Stearate,Polysorbate 60,Glyceryl Stearate,PEG-100 Stearate,Hydrogenated Starch Hydrolysate,Glycosyl Trehalose,Fragrance,Arginine,Acrylates/C10-30 Alkyl Acrylate Crosspolymer,Panthenol,Ethylhexylglycerin,Portulaca Oleracea Extract,Paeonia Suffruticosa Root Extract,Allantoin,Sodium Hyaluronate Crosspolymer,Hydrolyzed Collagen,Bisabolol,Ammonium Acryloyldimethyltaurate/VP Copolymer,Xanthan Gum,Tocopheryl Acetate,Hydrolyzed Glycosaminoglycans,Scutellaria Baicalensis Root Extract,Coptis Japonica Root Extract,Phellodendron Amurense Bark Extract,Rheum Palmatum Root Extract,Bletilla Striata Root Extract,Thioctic Acid,Glutathione,Tranexamic Acid,Disodium EDTA,Sodium Hyaluronate,Polycaprolactone,Ceramide NP,Hydrolyzed Hyaluronic Acid,Glycine,Serine,Glutamic Acid,Aspartic Acid,Leucine,Alanine,Lysine,Tyrosine,Phenylalanine,Threonine,Proline,Valine,Isoleucine,Pseudoalteromonas Ferment Extract,Histidine,Methionine,Cysteine,Citric Acid,Hyaluronic Acid,Croton Lechleri Resin Extract,Acetyl Hexapeptide-8,Copper Tripeptide-1,Palmitoyl Pentapeptide-4,Nicotinoyl Tripeptide-1,Nicotinoyl sh-Pentapeptide-19,Caffeoyl sh-Octapeptide-4,Caffeoyl Tripeptide-1,Digalloyl Tetrapeptide-19,Kojyl Carboxy Dipeptide-23,sh-Decapeptide-9,sh-Pentapeptide-5,sh-Polypeptide-69,sh-Polypeptide-1

Purpose

Purpose: Skin Brightening, Anti-wrinkle

Warnings

Warnings:For external use onlyAvoid contact with eyes.Do not use on damaged or irritated skin. Do not apply to the areas of skin with wounds, eczema, dermatitis or any other preconditions.Do not use in case of allergy to any of the ingredients. Use all the contents after opening (2g). To be used on the face only.Discontinue use and consult a dermatologist if signs of red spot, irritation or rashes appear.Avoid using additional facial scrub/peeling product, skin massage machine or beauty equipment. Avoid heavy exercise, sauna or bath that can heat up the skin before and after using the product. Avoid drinking or smoking after using the product. Keep the skin moisturized enough after using the product. After using the product, apply the sunscreen before sun exposure.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 TOX Ampoule with Microspear, Peptide, and Hydrolyzed Collagen helps skin brightening, anti-wrinkle and elasticity.

Directions

Directions:■ Once a week at night, after cleansing the face, apply one TOX Ampoule (2g) over the face and massage the skin with fingertips for absorption. After using the TOX Ampoule, wash your hands to prevent residues from getting to other parts of the body. Cleanse the face lightly the next morning. You may feel tingling temporarily.

* Please review the disclaimer below.

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