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

CELLADIX SKIN BARRIER RECOVERY 131 CREAM 
niacinamide, adenosine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83490-602
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83490-602-0180 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product05/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/24/2023
Labeler - 2359 US INC (118974080)
Registrant - 2359 US INC (118974080)
Establishment
NameAddressID/FEIBusiness Operations
isamogu Inc.695695834manufacture(83490-602)

Revised: 3/2023
Document Id: f6741846-7f62-3608-e053-2995a90adcc1
Set id: f6741846-7f61-3608-e053-2995a90adcc1
Version: 1
Effective Time: 20230309
 
2359 US INC