AROCELL TIME REVERSE K I T by FICC Co., Ltd. / COSON Co., Ltd._Osan Plant

AROCELL TIME REVERSE K I T by

Drug Labeling and Warnings

AROCELL TIME REVERSE K I T by is a Otc medication manufactured, distributed, or labeled by FICC Co., Ltd., COSON Co., Ltd._Osan Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AROCELL TIME REVERSE K I T- niacinamide 
FICC Co., Ltd.

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 INGREDIENTS

[AROCELL POWER ACTIVATOR]
NIACINAMIDE 2.0%
ADENOSINE 0.04%

[AROCELL POWER CELL]
NIACINAMIDE 10.0%

INACTIVE INGREDIENTS

[AROCELL POWER ACTIVATOR]
Water, Glycerin, Butylene Glycol, Propanediol, 1,2-Hexanediol, Polyglyceryl-10 Laurate, Ammonium Acryloyldimethyltaurate/VP, Sodium Hyaluronate, Human Cord Blood Cell Conditioned Media, Ethylhexylglycerin, Camellia Sinensis Leaf Extract, Fragrance, Glycyrrhiza Glabra (Licorice) Root Extract, Agrimonia Eupatoria Extract, Disodium EDTA, Perilla Frutescens Leaf Extract, Silybum Marianum Seed Extract, Broussonetia Kazinoki Root Extract, Propolis Extract, Cimicifuga Dahurica Root Extract, Salix Alba (Willow) Bark Extract, Oenothera Biennis (Evening Primrose) Flower

[AROCELL POWER CELL]
Water, Human Cord Blood Cell Conditioned Media, Sodium Hyaluronate, Betaine, Ascorbic Acid, Trehalose, 1,2-Hexanediol, Hydrolyzed Collagen

PURPOSE

[AROCELL POWER ACTIVATOR]
Skin Brightening
Anti wrinkle

[AROCELL POWER CELL]
Skin Brightening

WARNINGS

For external use only
Consult a specialist if there are abnormal symptoms or side effects such as redness, swelling or itchiness due to direct sunlight during or after use.
Avoid using on wounded areas.
Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

[AROCELL POWER ACTIVATOR]
■ Helps brighten skin tone
■ Helps improve wrinkle problem

[AROCELL POWER CELL]
■ Helps brighten skin tone

Directions

■ Take one Power Cell and open the cap by using the silver cylinder opener.
■ Pour Power Activator into the Power Cell up to the mark on the side of Power Cell.
■ Put on the white rubber cap onto the Power Cell and shake until the concentration dissolves.
■ Apply adequate amount on skin and gently massage for full absorption.
■ After use, put white rubber cap back. Use remaining ampoule within 7 days.

Other Information

■ Keep away from direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

AROCELL TIME REVERSE K I T 
niacinamide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81647-040
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81647-040-011 in 1 CARTON03/01/202110/01/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CONTAINER 70 mL
Part 21 CONTAINER 0.3 g
Part 1 of 2
AROCELL POWER ACTIVATOR 
niacinamide liquid
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE1.4 g  in 70 mL
Inactive Ingredients
Ingredient NameStrength
ADENOSINE (UNII: K72T3FS567)  
WATER (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
170 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other
Part 2 of 2
AROCELL POWER CELL 
niacinamide powder
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.03 g  in 0.3 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.3 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/01/202110/01/2022
Labeler - FICC Co., Ltd. (695721074)
Registrant - FICC Co., Ltd. (695721074)
Establishment
NameAddressID/FEIBusiness Operations
COSON Co., Ltd._Osan Plant689847210manufacture(81647-040)

Revised: 10/2023
 

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