MIRACLETOX TIME REWIND ADVANCED MASK- niacinamide, adenosine patch

MIRACLETOX Time Rewind Advanced Mask by

Drug Labeling and Warnings

MIRACLETOX Time Rewind Advanced Mask 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, Cetyl Ethylhexanoate, 1,2-Hexanediol, Butylene Glycol, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, PEG-100 Stearate, Glyceryl Stearate, Polysorbate 60, Betaine, Ammonium Acryloyldimethyltaurate/VP Copolymer, Dimethicone, Glyceryl Stearate SE, Stearic Acid, Sodium Hyaluronate, Hamamelis Virginiana (Witch Hazel) Extract, Xanthan Gum, Disodium EDTA, Fragrance, Tocopheryl Acetate, Alcohol, Portulaca Oleracea Extract,Tripeptide-29, Scutellaria Baicalensis Root Extract, Bletia Hyacinthina Bulb Extract, Coptis Chinensis Root Extract, Rheum Palmatum Root Extract, Phellodendron Amurense Bark Extract, Lactobacillus/Soybean Ferment Extract, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, PPG-26-Buteth-26, Caprylyl Glycol, PEG-40 Hydrogenated Castor Oil, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4, Copper Tripeptide-1, Palmitoyl Oligopeptide

PURPOSE

Purpose: Skin Brightening & Anti-wrinkle

WARNINGS

Warnings: For external use only. Use each mask (30g) only once. Avoid contact with the eyes. Discontinue use if signs of irritation or rashes appear. Do not use on damaged or broken skin.

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: 1.Take out the Mask and unfold the folded parts. 2. After adjusting the mask to your eyes, nose and mouth, attach the mask to your face. 3. Remove the mask after 10~20 minutes and tap lightly the essence left on your skin for absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIRACLETOX TIME REWIND ADVANCED MASK 
niacinamide, adenosine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71619-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.60 g  in 30 g
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.012 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetyl Ethylhexanoate (UNII: 134647WMX4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71619-020-02	4 in 1 CARTON	08/01/2017
1	NDC: 71619-020-01	30 g in 1 POUCH; 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(71619-020)