FDA.reportPublic FDA data

Celladix Skin Barrier Recovery 131 Cream

Manufacturer
2359 US INC | isamogu Inc.
Effective date
2023-03-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:30:58

Label at a glance#

ProductCelladix Skin Barrier Recovery 131 Cream
Active ingredientNIACINAMIDE, ADENOSINE
Label structure10 sections

Indications and uses

For skin barrier repair, perfect for oily skin.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Niacinamide 2.0%
Adenosine 0.04%

Purposes

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

For skin barrier repair, perfect for oily skin.

Warnings

OTC - DO NOT USE SECTION

Do not use it on open wounds and sensitive skin.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Warnings

OTC - STOP USE SECTION

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 SECTION

For external use only.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Celladix Skin Barrier Recovery 131 CreamCelladix Skin Barrier Recovery 131 Cream

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83490-602-012024-01-30C16284748780-11030e365-53ac-111a-e063-dadaa90a10e283490-602 Celladix Skin Barrier Recovery 131 Cream

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83490-60283490-602-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
STARCH, CORNO8232NY3SJIACT
GLYCERINPDC6A3C0OXIACT
PALMITIC ACID2V16EO95H1IACT
PENTYLENE GLYCOL50C1307PZGIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ALLANTOIN344S277G0ZIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
MANNITOL3OWL53L36AIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FIGTGD87RII2UIACT
NIACINAMIDE25X51I8RD4ACTIB
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DIOSCOREA JAPONICA ROOTI43FCF3356IACT
ALOE VERA LEAFZY81Z83H0XIACT
ADENOSINEK72T3FS567ACTIB
ARGININE94ZLA3W45FIACT
VIOLA MANDSHURICA FLOWER46MR945M6XIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CERAMIDE NP4370DF050BIACT
MYRISTIC ACID0I3V7S25AWIACT
HYALURONIC ACIDS270N0TRQYIACT
LAMINARIA JAPONICAWE98HW412BIACT
CAPRYLYL GLYCOL00YIU5438UIACT
STEARIC ACID4ELV7Z65APIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
ULMUS DAVIDIANA ROOTURQ79U8261IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1e63a6b0-1a90-1104-e063-6294a90ab71ff6741846-7f61-3608-e053-2995a90adcc12024-07-29WarningsExact identifier
spl set id: f6741846-7f61-3608-e053-2995a90adcc1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.