FDA.reportPublic FDA data

COSMEPURE DERMA REVITAL

Manufacturer
Cosmogen Co., Ltd.
Effective date
2021-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:35

Label at a glance#

ProductCOSMEPURE DERMA REVITAL
Active ingredientNiacinamide, Adenosine
Label structure10 sections

Indications and uses

■ Helps improve skin wrinkles and good for sensitive skin

Dosage and administration

■ Apply an appropriate amount evenly on the skin.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Niacinamide 2.0%
Adenosine 0.04%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Butylene Glycol, Cetearyl Olivate, Glycerin, Butylene Glycol Dicaprylate/Dicaprate, Sorbitan Olivate, Cetyl Ethylhexanoate, Cyclopentasiloxane, Propanediol, Glyceryl Stearate, Squalane, Cetearyl Alcohol, Argania Spinosa Kernel Oil, Macadamia Ternifolia Seed Oil, Butyrospermum Parkii (Shea) Butter, Dimethicone, Ammonium Acryloyldimethyltaurate/VP Copolymer, Panthenol, Caprylyl Glycol, Pentylene Glycol, Hydroxyacetophenone, Octyldodecanol, Allantoin, Hydrogenated Lecithin, Ceramide NP, Sodium Hyaluronate, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Punica Granatum Fruit Extract, Ficus Carica (Fig) Fruit Extract, Morus Alba Fruit Extract, Ginkgo Biloba Nut Extract, Cynanchum Wilfordii Root Extract, Centella Asiatica Extract, 1,2-Hexanediol, Ethylhexylglycerin, Arnebia Euchroma Extract, Angelica Gigas Root Extract, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Origanum Vulgare Flower/Leaf/Stem Extract, Thymus Vulgaris (Thyme) Extract, Scutellaria Baicalensis Root Extract

PURPOSE

OTC - PURPOSE SECTION

Skin brightening
Anti wrinkle

WARNINGS

WARNINGS SECTION

For external use only
Avoid contact with eyes.
Discontinue use if signs of irritation or rashes appear.
Replace the cap after use.
Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

■ Helps improve skin wrinkles and good for sensitive skin

Directions

DOSAGE & ADMINISTRATION SECTION

■ Apply an appropriate amount evenly on the skin.

Other information

OTHER SAFETY INFORMATION

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ADENOSINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81418-030-022024-01-30C16284748780-11030e365-5ab4-111a-e063-dadaa90a10e2d2a3ed07-313e-4f77-acaa-b572a449bd9d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81418-030-01COSMEPURE DERMA REVITAL50 mL in 1 CONTAINERCREAM501
81418-030-02COSMEPURE DERMA REVITAL1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81418-030COSMEPURE DERMA REVITAL (NIACINAMIDE, ADENOSINE) CREAM [COSMOGEN CO., LTD.]1Legacy NDC, 2 package rows20210130_d2a3ed07-313e-4f77-acaa-b572a449bd9d.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81418-03081418-030-01, 81418-030-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Niacinamide25X51I8RD4ACTIB
AdenosineK72T3FS567ACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

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
90f207eb-95d4-4577-a2b8-7bb2376707e5d2a3ed07-313e-4f77-acaa-b572a449bd9d2021-01-29WarningsExact identifier
spl id: 90f207eb-95d4-4577-a2b8-7bb2376707e5
spl set id: d2a3ed07-313e-4f77-acaa-b572a449bd9d

Reported adverse events (FAERS/openFDA)#

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