Costem cell 5 N

Manufacturer
COSTEMCELL.LTD.CO
Effective date
2016-11-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:01

Label at a glance#

ProductCostem cell 5 N
Active ingredientNiacinamide
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Niacinamide 2.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Human Stem Cell Conditioned Media, Glycerin, Butylene Glycol, Panthenol, Polysorbate 20, Copper Tripeptide-1, Acetyl Hexapeptide-8, Tripeptide-29, Palmitoyl Pentapeptide-4 , Nicotinoyl Tripeptide-1, Nicotinoyl Dipeptide-22, Nicotinoyl Dipeptide-23, Nonapeptide-1, sh-oligopeptide-1, sh-polypeptide-1, sh-polypeptide-11, sh-polypeptide-10, sh-polypeptide-9, sh-oligopeptide-2, Caprylyl Glycol, 1,2-Hexanediol, Polysorbate 60, Betaine, Squalane, Cucumis Sativus (Cucumber) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Argania Spinosa Kernel Oil, Pinus Densiflora Leaf Extract, Chamaecyparis Obtusa Oil, Sodium Hyaluronate, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Pentylene glycol, Panax Ginseng Root Extract, Astragalus Membranaceus Root Extract, Morus Alba Bark Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Aloe Barbadensis Leaf Extract, Sodium Phosphate, Lecithin, Superoxide Dismutase, Caprylhydroxamic Acid, Allantoin, Adenosine, Disodium EDTA

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Brightening

WARNINGS

WARNINGS SECTION

Warnings: Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Rinse with water to remove. Stop use if a rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indications & usage: Apply it to your face focusing on the oily parts, using the spray gently and evenly

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage & Administration: Take an adequate amount of this product. Use Once or several times a day.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809246212152GTIN-13: 8809246212152
EAN-13: 8809246212152
GTIN storage (14 digits): 08809246212152
costem cell 5 n carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71044-010-022020-01-31C16284748780-19d75b9d0-b94a-f424-e053-dadaa90a57ce8f908879-db12-4679-b5ca-d40aeb9d28fc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71044-010-01Costem cell 5 N5 mL in 1 VIALSOLUTION51
71044-010-02Costem cell 5 N18 in 1 CARTONSOLUTION181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71044-010COSTEM CELL 5 N (NIACINAMIDE) SOLUTION [COSTEMCELL.LTD.CO]1Legacy NDC, 2 package rows20161117_8f908879-db12-4679-b5ca-d40aeb9d28fc.zip

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
71044-01071044-010-01, 71044-010-02

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
Niacinamide25X51I8RD4ACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT

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
b8a1af1e-1d6d-460b-90db-b897e81c7f508f908879-db12-4679-b5ca-d40aeb9d28fc2016-11-17WarningsExact identifier
spl id: b8a1af1e-1d6d-460b-90db-b897e81c7f50
spl set id: 8f908879-db12-4679-b5ca-d40aeb9d28fc

Reported adverse events (FAERS/openFDA)#

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