83490-602 Celladix Skin Barrier Recovery 131 Cream

Celladix Skin Barrier Recovery 131 Cream by

Drug Labeling and Warnings

Celladix Skin Barrier Recovery 131 Cream by is a Otc medication manufactured, distributed, or labeled by 2359 US INC, isamogu Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CELLADIX SKIN BARRIER RECOVERY 131 CREAM- niacinamide, adenosine cream 
2359 US INC

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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83490-602 Celladix Skin Barrier Recovery 131 Cream

Active Ingredients

Niacinamide 2.0%
Adenosine 0.04%

Purposes

Niacinamide 2.0% ------ Skin protectant
Adenosine 0.04%------ Astringent

Uses

For skin barrier repair, perfect for oily skin.

Warnings

Do not use it on open wounds and sensitive skin.

Warnings

Keep out of reach of children.

Warnings

Stop use and ask a doctor If there are any abnormal symptoms or side effects such as red spots, swelling, or itching during or immediately after use.

Warnings

Warnings

For external use only.

Directions

Take an appropriate amount of the cream and gently spread it over the face for absorption

Inactive Ingredients

Water, Butylene Glycol, Glycerin, 1,2-Hexanediol, Dipropylene Glycol, Cetearyl Alcohol, Sodium Polyacryloyldimethyl Taurate, Carbomer, Arginine, Hydrogenated Lecithin,

Allantoin, Zea Mays (Corn) Starch, Microcrystalline Cellulose, Mannitol, Centella Asiatica Extract, Ficus Carica (Fig) Fruit Extract, Ethylhexylglycerin, Ceramide NP, Phytosterols,

Disodium EDTA, Palmitic Acid, Stearic Acid, Myristic Acid, Hyaluronic Acid, Pentylene Glycol, Dioscorea Japonica Root Extract, Laminaria Japonica Extract, Viola Mandshurica Flower Extract,

Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Lactobacillus Ferment

Label

CELLADIX SKIN BARRIER RECOVERY 131 CREAM 
niacinamide, adenosine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83490-602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	2 g  in 100 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.04 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
STARCH, CORN (UNII: O8232NY3SJ)
GLYCERIN (UNII: PDC6A3C0OX)
PALMITIC ACID (UNII: 2V16EO95H1)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALLANTOIN (UNII: 344S277G0Z)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MANNITOL (UNII: 3OWL53L36A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FIG (UNII: TGD87RII2U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARGININE (UNII: 94ZLA3W45F)
VIOLA MANDSHURICA FLOWER (UNII: 46MR945M6X)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CERAMIDE NP (UNII: 4370DF050B)
MYRISTIC ACID (UNII: 0I3V7S25AW)
HYALURONIC ACID (UNII: S270N0TRQY)
LAMINARIA JAPONICA (UNII: WE98HW412B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARIC ACID (UNII: 4ELV7Z65AP)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83490-602-01	80 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	05/24/2023	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/24/2023	07/29/2024

Labeler - 2359 US INC (118974080)

Registrant - 2359 US INC (118974080)

Establishment
Name	Address	ID/FEI	Business Operations
isamogu Inc.		695695834	manufacture(83490-602)

Revised: 7/2024

Document Id: 1e63a6b0-1a90-1104-e063-6294a90ab71f

34390-5

Set id: f6741846-7f61-3608-e053-2995a90adcc1

Version: 2

Effective Time: 20240729