MIRACLETOX TIME REWIND PERFECTION TOX AMPOULE- niacinamide, adenosine liquid

MIRACLETOX Time Rewind Perfection TOX Ampoule by

Drug Labeling and Warnings

MIRACLETOX Time Rewind Perfection 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, Dicaprylate/Dicaprate, Hydrolyzed Sponge, Butylene Glycol, Cetyl Ethylhexanoate, Glycerin, 1,2-Hexanediol, Cetearyl Alcohol, Macadamia Ternifolia Seed Oil, Butyrospermum Parkii (Shea) Butter, Dimethicone, Polyglutamic Acid, Sorbitan Stearate, Polysorbate 60, Glyceryl Stearate, PEG-100 Stearate, Cyclopentasiloxane, Panthenol, Simmondsia Chinensis (Jojoba) Seed Oil, Asparagus Officinalis Extract, Hydrogenated Starch Hydrolysate, Cyclohexasiloxane, Glycosyl Trehalose, Fragrance, Arginine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Nelumbo Nucifera Callus Culture Extract, Beta-Glucan, Portulaca Oleracea Extract, Paeonia Suffruticosa Root Extract, Ethylhexylglycerin, Tocopheryl Acetate, Chondrus Crispus Powder, Allantoin, Agar, Titanium Dioxide(CI 77891), Synthetic Fluorphlogopite, Tromethamine, Red Oxide of Iron(CI 77491), Mica, Ammonium Acryloyldimethyltaurate/VP Copolymer, Scutellaria Baicalensis Root Extract, Coptis Japonica Root Extract, Phellodendron Amurense Bark Extract, Rheum Palmatum Root Extract, Bletilla Striata Root Extract, Sodium Hyaluronate, Xanthan Gum, Disodium EDTA, Glycine, Serine, Glutamic Acid, Aspartic Acid, Leucine, Algin, Pectin, Gellan Gum, Alanine, Lysine, Tyrosine, Phenylalanine, Threonine, Proline, Valine, Isoleucine, Ceramide NP, Citric Acid, Histidine, Methionine, Cysteine, Alanine/Histidine/Lysine Polypeptide Copper HCl, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4, sh-Oligopeptide-1, sh-Polypeptide-1

PURPOSE

Purpose: Skin Brightening, Anti-wrinkle

WARNINGS

Warnings:

For external use only

Avoid contact with eyes.

Use each product (2g) only once.

Discontinue use if signs of irritation or rashes appear.

Do not use on damaged or broken skin.

Do not use the product on other areas (neck, back of hand, etc.) except for the face.

Avoid using additional facial scrub/peeling product, skin massage machine, or beauty equipment.

Avoid excessive exercise, sauna or bath that can heat up your skin before and after using the product.

Avoid drinking or smoking after using the product.

Keep your skin moisturized enough after using the product.

Keep out of reach of children.

Not intended for use by children under 13 years of age.

Store product in a cool(20-25℃, 68-77℉) place and avoid direct sunlight and high humidity.

After using the product, apply the sunscreen before sun exposure.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

Helps skin brightening and anti-wrinkle.

Directions

Directions:

Once a week at night, after cleansing your face, apply the product evenly over your face and massage your skin with fingertips for absorption. After using the product, wash your hands so that residues do not touch other parts of body. Cleanse your face lightly the next morning. You may feel tingling temporarily. Recommended to use 2g once a week at night.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIRACLETOX TIME REWIND PERFECTION TOX AMPOULE 
niacinamide, adenosine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71619-210
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: 71619-210-02	4 in 1 CARTON	04/01/2018
1	NDC: 71619-210-01	2 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2018

Labeler - Beauren Korea Inc. (689700249)

Registrant - Beauren Korea Inc. (689700249)

Establishment
Name	Address	ID/FEI	Business Operations
Dermafirm INC.		690171603	manufacture(71619-210)