FDA.reportPublic FDA data

Celladix Sebum Rebalancing Rx 131 Ampoule

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 Sebum Rebalancing Rx 131 Ampoule
Active ingredientNIACINAMIDE, ADENOSINE
Label structure10 sections

Indications and uses

For skin barrier repair, perfect for oily skin

Dosage and administration

After cleansing or toning, take an appropriate amount of the ampoule 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

WARNINGS SECTION

For external use only.

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

Directions

DOSAGE & ADMINISTRATION SECTION

After cleansing or toning, take an appropriate amount of the ampoule and gently spread it over the face for absorption

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Dipropylene Glycol, Butylene Glycol, Glycereth-26, Niacinamide, Glycerin, Betain, Phytosterols, Ceramide NP, Squalane, Lauric Acid, Arachidic Acid, Behenic Acid, Beta-Glucan, Paulownia Tomentosa Leaf Extract, Cinnamomum Cassia Bark Extract, Cinnamomum Japonicum Leaf Extract, Cinnamomum Camphora (Camphor) Leaf Extract, Laurus Nobilis Leaf Extract, Coriandrum Sativum (Coriander) Extract, Eucalyptus Globulus Leaf Extract, Scutellaria Baicalensis Root Extract, Machilus Thunbergii Branch Extract, 1,2-Hexanediol, Polyglyceryl-10 Laurate, Polyglyceryl-10 Myristate, Hydroxyacetophenone, Panthenol, Adenosine, Disodium EDTA, Sodium Hyaluronate, Xanthan Gum, Sodium Polyacrylate, Ethylhexylglycerin, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Hybrida Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Amyris Balsamifera Bark Oi, Ocimum Basilicum (Basil) Oil, Limonene, Linalool

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Celladix Sebum Rebalancing Rx 131 AmpouleCelladix Sebum Rebalancing Rx 131 Ampoule

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83490-601-012024-01-30C16284748780-11030e365-2954-111a-e063-dadaa90a10e283490-601 Celladix Sebum Rebalancing Rx 131 Ampoule

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83490-60183490-601-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURIC ACID1160N9NU9UIACT
BEHENIC ACIDH390488X0AIACT
CINNAMOMUM CAMPHORA LEAFA0TKE4ZO0SIACT
BAY LEAFWS0Y3M85RFIACT
DIPROPYLENE GLYCOLE107L85C40IACT
GLYCERINPDC6A3C0OXIACT
BETAINE3SCV180C9WIACT
ARACHIDIC ACIDPQB8MJD4RBIACT
PAULOWNIA TOMENTOSA LEAFD175ZR7P0CIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
POLYGLYCERYL-10 MYRISTATEY9WL8QN3ZBIACT
PANTHENOLWV9CM0O67ZIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
XANTHAN GUMTTV12P4NEEIACT
AMYRIS BALSAMIFERA OILI1BJ961J2EIACT
LAVANDIN OIL9RES347CKGIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CERAMIDE NP4370DF050BIACT
SQUALANEGW89575KF9IACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CORIANDRUM SATIVUM WHOLE740M8BF6EFIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
BASIL OILZ129UMU8LEIACT
LINALOOL, (+/-)-D81QY6I88EIACT
ORANGE OILAKN3KSD11BIACT
WATER059QF0KO0RIACT
LAVENDER OILZBP1YXW0H8IACT
GLYCERETH-26NNE56F2N14IACT
CHINESE CINNAMONWS4CQ062KMIACT
MACHILUS THUNBERGII BRANCH301F5K1I0RIACT
HYALURONATE SODIUMYSE9PPT4THIACT
BERGAMOT OIL39W1PKE3JIIACT
NIACINAMIDE25X51I8RD4ACTIB
ADENOSINEK72T3FS567ACTIB
LIMONENE, (+)-GFD7C86Q1WIACT

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
1e639f84-8e47-6d0b-e063-6394a90a3096f673e59f-7c53-3e2c-e053-2995a90ac7b52024-07-29WarningsExact identifier
spl set id: f673e59f-7c53-3e2c-e053-2995a90ac7b5

Reported adverse events (FAERS/openFDA)#

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