FDA.reportPublic FDA data

DR.K CELL REPAIR GENIC AMPOULE

Manufacturer
Noblesse Korea Co., Ltd.
Effective date
2023-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:44

Label at a glance#

ProductDR.K CELL REPAIR GENIC AMPOULE
Active ingredientACETYL HEXAPEPTIDE-8, NONAPEPTIDE-1, PALMITOYL PENTAPEPTIDE-4, ALANINE, PRUNUS X YEDOENSIS FLOWER
Label structure11 sections

Indications and uses

Shake the ampoule lightly before use. Apply to cleansed areas of face and neck and gently rub into area.

Dosage and administration

Shake the ampoule lightly before use. Apply to cleansed areas of face and neck and gently rub into area. 1. Open the upper cover 2. Tear up the metal cap 3. Remove the rubber top 4. Replace an applicator

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Prunus Yedoensis Sprout Cell Extract, Acetyl Hexapeptide-8, Tetrapeptide-51, Palmitoyl Pentapeptide-4, Nonapeptide-1

Purposes

OTC - PURPOSE SECTION

helps with brightening, wrinkle improvement, and strengthening the skin barrier.

Uses

INDICATIONS & USAGE SECTION

Shake the ampoule lightly before use. Apply to cleansed areas of face and neck and gently rub into area.

Warnings

OTC - DO NOT USE SECTION

Do not use, in the event of skin irritation or rash

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 irritation develops.

Warnings

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, flush your eyes with a copious amount of water.

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

Shake the ampoule lightly before use. Apply to cleansed areas of face and neck and gently rub into area.

1. Open the upper cover 2. Tear up the metal cap 3. Remove the rubber top 4. Replace an applicator

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Centella Asiatica Leaf
Water, Water, Prunus Yedoensis Sprout Cell Extract ,
Glycerin, Isohexadecane, Dipropylene Glycol, Butylene
Glycol, Octyldodecyl Myristate, Niacinamide, Acetyl
Hexapeptide-8, Copper Tripeptide-1, sh-Polypeptide-9(
VEGF), sh-Polypeptide-1(bFGF), sh-Oligopeptide-2(
IGF-1), sh-Oligopeptide-1(EGF), Tetrapeptide-51,
Nicotinoyl Dipeptide-22, Nicotinoyl Dipeptide-23,
Palmitoyl Pentapeptide-4, Tripeptide-29, Nicotinoyl
Tripeptide-1, Nonapeptide-1, te, Tropaeolum Majus
Extract, Myrtus Communis Extract, Biosaccharide Gum
-1, Polyglyceryl-4 Caprate, Tocopherol,
Ethylhexylglycerin, Polyglyceryl-10 Laurate, Stearic
Acid, Sophora Japonica Flower Extract, Lavandula
Angustifolia (Lavender) Oil, Linalool.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Noblesse Korea_LabelNoblesse Korea_Label

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83153-301-012024-07-30C16284748780-11030e365-1947-111a-e063-dadaa90a10e283153-301 DR.K CELL REPAIR GENIC AMPOULE
83153-301-012024-01-30C16284748780-11030e365-1947-111a-e063-dadaa90a10e283153-301 DR.K CELL REPAIR GENIC AMPOULE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83153-301-01DR.K CELL REPAIR GENIC AMPOULE6 mL in 1 BOTTLE, WITH APPLICATORSOLUTION61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83153-301DR.K CELL REPAIR GENIC AMPOULE (PRUNUS YEDOENSIS SPROUT CELL EXTRACT, ACETYL HEXAPEPTIDE-8, TETRAPEPTIDE-51, PALMITOYL PENTAPEPTIDE-4, NONAPEPTIDE-1) SOLUTION [NOBLESSE KOREA CO., LTD.]11 package rows20230726_fe2709ae-4e91-a705-e053-6394a90a786f.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83153-30183153-301-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
CENTELLA ASIATICA LEAF6810070TYDIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OCTYLDODECYL MYRISTATES013N99GR8IACT
NIACINAMIDE25X51I8RD4IACT
ACETYL HEXAPEPTIDE-8L4EL31FWILACTIB
PREZATIDE COPPER6BJQ43T1I9IACT
BASIC FIBROBLAST GROWTH FACTOR (HUMAN)S3529G9M9VIACT
TRIPEPTIDE-29X6346H6PUMIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
ISOHEXADECANE918X1OUF1EIACT
HUMAN VASCULAR ENDOTHELIAL GROWTH FACTOR ANZN256ZSV8IACT
NONAPEPTIDE-164W45420K5ACTIB
BETAINE3SCV180C9WIACT
ADENOSINEK72T3FS567IACT
TROMETHAMINE023C2WHX2VIACT
GRAPE SEED OIL930MLC8XGGIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HUMAN EPIDERMAL GROWTH FACTORTZK30RF92WIACT
ANEMARRHENA ASPHODELOIDES ROOTU0OC9BJL0IIACT
HIPPOPHAE RHAMNOIDES FRUITAVL0R9111TIACT
MECASERMIN7GR9I2683OIACT
PALMITOYL PENTAPEPTIDE-4KK181SM5JGACTIB
TREMELLA FUCIFORMIS FRUITING BODYGG8N28393GIACT
DIOSCOREA JAPONICA ROOTI43FCF3356IACT
PANTHENOLWV9CM0O67ZIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALANINEOF5P57N2ZXACTIB
PRUNUS X YEDOENSIS FLOWER717640J2LVACTIB
DIPROPYLENE GLYCOLE107L85C40IACT
ALMOND OIL66YXD4DKO9IACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
MADECASSOSIDECQ2F5O6YIYIACT
ARGAN OIL4V59G5UW9XIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ASIATICOSIDEPKO39VY215IACT

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
fe2709ae-4e92-a705-e053-6394a90a786ffe2709ae-4e91-a705-e053-6394a90a786f2023-06-15WarningsExact identifier
spl id: fe2709ae-4e92-a705-e053-6394a90a786f
spl set id: fe2709ae-4e91-a705-e053-6394a90a786f

Reported adverse events (FAERS/openFDA)#

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