MIRACLETOX TIME REWIND PERFECTION MASK- niacinamide, adenosine patch

MIRACLETOX Time Rewind Perfection Mask by

Drug Labeling and Warnings

MIRACLETOX Time Rewind Perfection 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, Glyceryl Stearate SE, Stearic Acid, Hamamelis Virginiana (Witch Hazel) Extract, Portulaca Oleracea Extract, Xanthan Gum, Disodium EDTA, Fragrance, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Helichrysum Arenarium Extract, Adansonia Digitata Seed Oil, Hydrogenated Lecithin, Lactobacillus/Soybean Ferment Extract, Ceramide NP, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Origanum Vulgare Flower/Leaf/Stem Extract, Thymus Vulgaris (Thyme) Extract, Sodium Hyaluronate, Scutellaria Baicalensis Root Extract, Bletilla Striata Root Extract, Coptis Japonica Root Extract, Rheum Palmatum Root Extract, Phellodendron Amurense Bark Extract, Ceramide NS, Ceramide AS, Alcohol, PEG-40 Hydrogenated Castor Oil, PPG-26-Buteth-26, Ceramide EOP, Ceramide AP, Caprylyl Glycol, Palmitoyl Oligopeptide, Copper Tripeptide-1, Tripeptide-29, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4

PURPOSE

Purpose: Skin Brightening, Anti-wrinkle

WARNINGS

Warnings:

For external use only

Avoid contact with eyes.

Use each mask (30g) only once.

Discontinue use if signs of irritation or rashes appear. Do not use on damaged or broken skin.

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

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, put it on your face.

3. Remove the mask after 20~30 minutes and tap lightly the essence left on your skin for absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIRACLETOX TIME REWIND PERFECTION MASK 
niacinamide, adenosine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71619-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	0.6 g  in 30 g
Adenosine (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	Adenosine	0.01 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
1,2-Hexanediol (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71619-200-02	4 in 1 CARTON	04/01/2018
1	NDC: 71619-200-01	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		04/01/2018

Labeler - Beauren Korea Inc. (689700249)

Registrant - Beauren Korea Inc. (689700249)

Establishment
Name	Address	ID/FEI	Business Operations
Dermafirm INC.		690171603	manufacture(71619-200)