AROCELL MOISTURIZING by FICC Co., Ltd. / COSON Co., Ltd._Osan Plant

AROCELL MOISTURIZING by

Drug Labeling and Warnings

AROCELL MOISTURIZING 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 MOISTURIZING- niacinamide, adenosine cream 
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

NIACINAMIDE 2.0%
ADENOSINE 0.04%

INACTIVE INGREDIENTS

Water, Glycerin, Caprylic/Capric Triglyceride, Caprylic/Capric/Succinic Triglyceride, Butylene Glycol, Propanediol, Cyclohexasiloxane, Cetearyl Olivate, Dicaprylyl Carbonate, Cetearyl Alcohol, 1,2-Hexanediol, Sorbitan Olivate, Butyrospermum Parkii (Shea) Butter, Donkey Milk, Glyceryl Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Carbomer, Tromethamine, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Human Cord Blood Cell Conditioned Media, Xanthan Gum, Palmitic Acid, Ethylhexylglycerin, Stearic Acid, Disodium EDTA, Salvia Officinalis (Sage) Oil, Dipotassium Glycyrrhizate, Panthenol, Tranexamic Acid, Hydrolyzed Jojoba Esters, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Agrimonia Eupatoria Extract, Biosaccharide Gum-1, Centella Asiatica Extract, Houttuynia Cordata Extract, Perilla Frutescens Leaf Extract, Salvia Hispanica Seed Extract, Silybum Marianum Seed Extract, Sodium Hyaluronate, Beta-Glucan, Broussonetia Kazinoki Root Extract, Propolis Extract, Cimicifuga Dahurica Root Extract, Salix Alba (Willow) Bark Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Limonene, Linalool

PURPOSE

Skin Brightening
Anti-wrinkle

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

■ Helps brighten skin tone
■ Helps improve wrinkle problem

Directions

■ Apply an appropriate amount and massage gently into skin at the last stage of skin care routine.

Other Information

■ Keep away from direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AROCELL MOISTURIZING 
niacinamide, adenosine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81647-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	1.0 g  in 50 g
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.02 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81647-010-02	1 in 1 CARTON	03/01/2021	10/01/2022
1	NDC: 81647-010-01	50 g 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		03/01/2021	10/01/2022

Labeler - FICC Co., Ltd. (695721074)

Registrant - FICC Co., Ltd. (695721074)

Establishment
Name	Address	ID/FEI	Business Operations
COSON Co., Ltd._Osan Plant		689847210	manufacture(81647-010)

Revised: 10/2023

Document Id: c9364d78-2525-4fac-8902-91bc8433875b

34390-5

Set id: 3fad1028-d387-403d-bc5d-c078816e8645

Version: 3

Effective Time: 20231016