MIRACLETOX TIME REWIND BEYOND TOX AMPOULE- niacinamide, adenosine liquid

MIRACLETOX Time Rewind Beyond TOX Ampoule by

Drug Labeling and Warnings

MIRACLETOX Time Rewind Beyond TOX Ampoule by is a Otc medication manufactured, distributed, or labeled by Beauren Korea Inc., Dermafirm INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 only
Avoid 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIRACLETOX TIME REWIND BEYOND TOX AMPOULE 
niacinamide, adenosine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71619-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	0.04 g  in 2 g
Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	Adenosine	0.0008 g  in 2 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71619-250-02	4 in 1 CARTON	03/01/2019
1	NDC: 71619-250-01	2 g in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2019

Labeler - Beauren Korea Inc. (689700249)

Registrant - Beauren Korea Inc. (689700249)

Establishment
Name	Address	ID/FEI	Business Operations
Dermafirm INC.		690171603	manufacture(71619-250)