MIRACLETOX TIME REWIND ADVANCED TOX AMPOULE- niacinamide, adenosine liquid

MIRACLETOX Time Rewind Advanced TOX Ampoule by

Drug Labeling and Warnings

MIRACLETOX Time Rewind Advanced 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,1,2-Hexanediol, Dimethicone, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Stearyl Alcohol, Glycerin, Phytosqualane, Macadamia Ternifolia Seed Oil, Panthenol, Glyceryl Stearate, Caprylyl Glycol, Perfume, Beta-Glucan, Allantoin, Portulaca Oleracea Extract, Octyldodecanol, Carbomer, Disodium EDTA, Hydrogenated Lecithin, Scutellaria Baicalensis Root Extract, Coptis Japonica Root Extract, Phellodendron Amurense Bark Extract, Rheum Palmatum Root Extract, Bletia Hyacinthina Bulb Extract, Sodium Hyaluronate, Ceramide NP, Dipotassium Glycyrrhizate, Citric Acid, Velvet Extract, Ganoderma Lucidum (Mushroom) Stem Extract, Panax Ginseng Root Extract, Asparagus Cochinchinensis Root Extract, Astragalus Membranaceus Root Extract, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Caprylic/Capric Triglyceride, Cholesterol, Sodium PCA, Betaine, Sorbitol, Glycine, Alanine, Proline, Serine, Threonine, Lysine, Glutamic Acid, Copper Tripeptide-1, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4, rh-Polypeptide-1, rh-Oligopeptide-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 other than cooling device. Avoid excessive exercise, sauna or bath that can heat up your skin before and after using this product. Avoid drinking or smoking after using this product. Keep your skin moisturized enough after using this product. Use the sunscreen at all times.

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children. Store away from hot or cold places and direct sunlight.

Uses

Uses: Helps skin brightening and anti-wrinkle.

Directions

Directions: After cleansing your face, apply TOX Ampoule evenly over your face and massage your skin with fingertips for absorption. 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 ADVANCED TOX AMPOULE 
niacinamide, adenosine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71619-050
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: 71619-050-02	4 in 1 CARTON	08/01/2017
1	NDC: 71619-050-01	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		08/01/2017

Labeler - Beauren Korea Inc. (689700249)

Registrant - Beauren Korea Inc. (689700249)

Establishment
Name	Address	ID/FEI	Business Operations
Dermafirm INC.		690171603	manufacture(71619-050)