FDA.reportPublic FDA data

Clapiel Revital Serum

Manufacturer
AUS KOREA CO., LTD.
Effective date
2015-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:09

Label at a glance#

ProductClapiel Revital Serum
Active ingredientDimethicone
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Dimethicone 20.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Cyclopentasiloxane, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Cyclohexasiloxane, Linum Usitatissimum (Linseed) Seed Oil, Camellia Japonica Seed Oil, Macadamia Ternifolia Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Pichia Anomala Extract, Yeast Extract, Myrothamnus Flabellifolia Callus Culture Extract, Pentylene Glycol, Hydrolyzed Myrtus Communis Leaf Extract, Undaria Pinnatifida Extract, Lactuca Indica Extract, Corydalis Ochotensis Extract, Draba Nemorosa Extract, Chenopodium Album Flower Extract, Lactobacillus/Soybean Ferment Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Scultellaria Baicalensis Root Extract, Portulaca Oleracea Extract

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of babies and children

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indications & Usage: Apply a desired amount evenly over entire face.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
417545dimethicone 20 % Topical CreamPSN1
417545dimethicone 200 MG/ML Topical CreamSCD1
417545dimethicone 20 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69977-040-012020-01-31C16284748780-19d75b9cf-ee6a-f424-e053-dadaa90a57ce91ed69fe-000f-4273-a323-0a856b6e5539

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69977-040-01Clapiel Revital Serum30 mL in 1 CARTONCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69977-040CLAPIEL REVITAL SERUM (DIMETHICONE) CREAM [AUS KOREA CO., LTD.]1Legacy NDC, 1 package rows20150724_91ed69fe-000f-4273-a323-0a856b6e5539.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DimethiconeACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
SqualaneINACTIVE INGREDIENTGW89575KF91

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69977-04069977-040-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Dimethicone92RU3N3Y1OACTIB
SqualaneGW89575KF9IACT
JOJOBA OIL724GKU717MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 5 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SqualaneSQUALANEGW89575KF9SOLUTION / TOPICAL1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
SqualaneSQUALANEGW89575KF9CREAM / TOPICAL6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
SqualaneSQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii candidate
5 equally ranked IID candidates
SqualaneSQUALANEGW89575KF9POWDER / ORAL0.02 mgExact identifier — unii candidate
5 equally ranked IID candidates
SqualaneSQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii candidate
5 equally ranked IID candidates

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
adfd7f1c-08da-4038-a450-6639ff56a5bc91ed69fe-000f-4273-a323-0a856b6e55392015-07-24WarningsExact identifier
spl id: adfd7f1c-08da-4038-a450-6639ff56a5bc
spl set id: 91ed69fe-000f-4273-a323-0a856b6e5539

Reported adverse events (FAERS/openFDA)#

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