MIRACLETOX TIME REWIND ADVANCED LIFTING AMPOULE 40ML- niacinamide, adenosine liquid

MIRACLETOX Time Rewind Advanced Lifting Ampoule by

Drug Labeling and Warnings

MIRACLETOX Time Rewind Advanced Lifting 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, Glycerin, Butylene Glycol, 1,2-Hexanediol, Betaine, Beta-Glucan, Hydrolyzed Jojoba Esters, PEG-60 Hydrogenated Castor Oil, Carbomer, Butyrospermum Parkii (Shea) Butter, Sparassis Crispa Extract, Panthenol, Allantoin, Hydroxyethylcellulose, Fragrance, Cyclopentasiloxane, Disodium EDTA, Hydrogenated Lecithin, Lecithin, Glycine, Histidine, Serine, Glutamic Acid, Saccharomyces/Viscum Album (Mistletoe) Ferment Extract, Hydrolyzed Collagen, Aspartic Acid, Leucine, Lactobacillus/Soybean Ferment Extract, Scutellaria Baicalensis Root Extract, Bletia Hyacinthina Bulb Extract, Coptis Chinensis Root Extract, Rheum Palmatum Root Extract, Phellodendron Amurense Bark Extract, Alanine, Lysine, Saccharomyces/Imperata Cylindrica Root Ferment Extract, Arginine, Tyrosine, Phenylalanine, Threonine, Proline, Valine, Isoleucine, Lactobacillus/Rice Ferment Filtrate, Cysteine, Methionine, Pentylene Glycol, Alcohol, PEG-40 Hydrogenated Castor Oil, PPG-26-Buteth-26, Sodium Phosphate, Caprylyl Glycol, Copper Tripeptide-1, Acetyl Hexapeptide-8,Palmitoyl Pentapeptide-4, sh-Oligopeptide-1

PURPOSE

Purpose: Skin Brightening & Anti-wrinkle

WARNINGS

Warnings:

For external use only.

Avoid contact with eyes.

Discontinue use if signs of irritation or rashes appear.

Do not use on damaged or broken skin.

Close the cap after use.

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: Spread Lifting Ampoule evenly along your skin and tap it lightly for absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIRACLETOX TIME REWIND ADVANCED LIFTING AMPOULE   40ML
niacinamide, adenosine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71619-180
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.8 g  in 40 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.016 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71619-180-02	1 in 1 CARTON	11/01/2017
1	NDC: 71619-180-01	40 mL 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		11/01/2017

Labeler - Beauren Korea Inc. (689700249)

Registrant - Beauren Korea Inc. (689700249)

Establishment
Name	Address	ID/FEI	Business Operations
Dermafirm INC.		690171603	manufacture(71619-180)