FDA.reportPublic FDA data

METABOLIC INTENSIVE CARE

Manufacturer
rootsallo Qwell | Elan Cosmetic Co.,ltd
Effective date
2021-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:07

Label at a glance#

ProductMETABOLIC INTENSIVE CARE
Active ingredientAdenosine, .ALPHA.-BISABOLOL, (+/-)-
Label structure10 sections

Indications and uses

Helps to have balanced skincare with rich nutrition and deep moisturizing effects on the skin.

Dosage and administration

Apply an appropriate amount on the skin and pat evenly.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Adenosine 0.04%
.ALPHA.-BISABOLOL, (+/-)- 0.5%

PURPOSE

OTC - PURPOSE SECTION

Anti wrinkle, Whitening

Uses

INDICATIONS & USAGE SECTION

Helps to have balanced skincare with rich nutrition and deep moisturizing effects on the skin.

Warnings

WARNINGS SECTION

For external use only.
In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic consult a dermatologist immediately.
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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply an appropriate amount on the skin and pat evenly.

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Propanediol, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Isoamyl Laurate, Cetearyl Alcohol, Macadamia Integrifolia Seed Oil, Glycerin, Glyceryl Stearate SE, Cetearyl Olivate, Hydrogenated Vegetable Oil, Hydrogenated Olive Oil, Cetearyl Glucoside, Stearic Acid, Palmitic Acid, Sorbitan Olivate, Chamaecyparis Obtusa Oil, Olea Europaea (Olive) Fruit Oil, Tocopherol, Scutellaria Baicalensis Root Extract, Arginine, Olea Europaea (Olive) Oil Unsaponifiables, p-Anisic Acid, Centella Asiatica Extract, Paeonia Suffruticosa Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Hyaluronate, Cetyl Alcohol, Stearyl Alcohol, Citric Acid, Polygonum Cuspidatum Root Extract, Aloe Barbadensis Leaf Extract, Xanthan Gum, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Bioflavonoids, Beta-Glucan, Brassica Oleracea Italica (Broccoli) Extract, *Limonene (essential oil component)

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
82450-020-022023-01-30C16284748780-1f386c649-bd01-0266-e053-dadaa90a7c1acba70640-3dc4-4af2-a087-0ec19a8ba55c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82450-020-01METABOLIC INTENSIVE CARE50 mL in 1 CONTAINERCREAM501
82450-020-02METABOLIC INTENSIVE CARE1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82450-020METABOLIC INTENSIVE CARE (ADENOSINE, ALPHA BISABOLOL) CREAM [ROOTSALLO QWELL]1Legacy NDC, 2 package rows20211231_cba70640-3dc4-4af2-a087-0ec19a8ba55c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82450-02082450-020-01, 82450-020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
AdenosineK72T3FS567ACTIB
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCACTIB
Water059QF0KO0RIACT
Propanediol5965N8W85TIACT
SHEA BUTTERK49155WL9YIACT

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
a8c04c10-2ddc-408b-a1b4-b8ec072abe65cba70640-3dc4-4af2-a087-0ec19a8ba55c2021-12-30WarningsExact identifier
spl id: a8c04c10-2ddc-408b-a1b4-b8ec072abe65
spl set id: cba70640-3dc4-4af2-a087-0ec19a8ba55c

Reported adverse events (FAERS/openFDA)#

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