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MIRACLETOX Time Rewind Advanced Mask

Medically reviewed on September 12, 2017

Dosage form: patch
Ingredients: NIACINAMIDE 0.60g in 30g, ADENOSINE 0.012g in 30g
Labeler: Beauren Korea Inc.
NDC Code: 71619-020

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.

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

MIRACLETOX TIME REWIND ADVANCED MASK 
niacinamide, adenosine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71619-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE0.60 g  in 30 g
ADENOSINE (ADENOSINE) ADENOSINE0.012 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
Water 
Cetyl Ethylhexanoate 
Packaging
#Item CodePackage Description
1NDC:71619-020-024 POUCH in 1 CARTON
1NDC:71619-020-0130 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2017
Labeler - Beauren Korea Inc. (689700249)
Registrant - Beauren Korea Inc. (689700249)
Establishment
NameAddressID/FEIOperations
Dermafirm INC.690171603manufacture(71619-020)

 
Beauren Korea Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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