MIRACLETOX TIME REWIND ADVANCED TOX AMPOULE- niacinamide, adenosine liquid 
Beauren Korea Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

Image of carton

MIRACLETOX TIME REWIND ADVANCED TOX AMPOULE 
niacinamide, adenosine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71619-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.04 g  in 2 g
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.0008 g  in 2 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71619-050-024 in 1 CARTON08/01/201712/31/2020
1NDC:71619-050-012 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/201712/31/2020
Labeler - Beauren Korea Inc. (689700249)
Registrant - Beauren Korea Inc. (689700249)
Establishment
NameAddressID/FEIBusiness Operations
Dermafirm INC.690171603manufacture(71619-050)

Revised: 12/2020
 
Beauren Korea Inc.