Dr Cellinme Skin Care Ampoule

Manufacturer
Dr.Gene Co.,Ltd
Effective date
2015-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:10

Label at a glance#

ProductDr Cellinme Skin Care Ampoule
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, METHYLPROPANEDIOL, GLYCERIN, BETAINE, DIGLYCERIN, POLYQUATERNIUM-51, PIPER METHYSTICUM LEAF/ROOT/STEM EXTRACT, ALOE BARBADENSIS LEAF JUICE, 1,2-HEXANEDIOL, ARCTIUM LAPPA ROOT EXTRACT, PHELLINUS LINTEUS EXTRACT, SOLUBLE COLLAGEN, HYDROGENATED LECITHIN, GLYCOSYL TREHALOSE, PHENOXYETHANOL, HYDROGENATED STARCH HYDROLYSATE, XANTHAN GUM, DIOSCOREA JAPONICA ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, PUERARIA THUNBERGIANA ROOT EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT, TROMETHAMINE, ETHYLHEXYLGLYCERIN, PORIA COCOS SCLEROTIUM EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, NYMPHAEA ALBA FLOWER EXTRACT, DIPROPYLENE GLYCOL, CELLULOSE GUM, ADENOSINE, DISODIUM EDTA, FRAGRANCE, SODIUM HYALURONATE, SODIUM PALMITOYL PROLINE, BUTYLENE GLYCOL, BIS-PEG-18 METHYL ETHER DIMETHYL SILANE, PEG/PPG-17/6 COPOLYMER, PEG-40 HYDROGENATED CASTOR OIL, CARBOMER, PVM/MA COPOLYMER, SODIUM POLYACRYLATE, RAFFINOSE, BIOSACCHARIDE GUM-1, LECITHIN, FOLIC ACID, CERAMIDE 3, CHOLESTEROL, CAPRYLYL GLYCOL, PANTHENOL, PALMITOYL TRIPEPTIDE-5, ACETYL HEXAPEPTIDE-8, PALMITOYL PENTAPEPTIDE-4

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings: 1. You must immediately discontinue using the product if any of the following symptoms occur, and since a prolonged usage will aggressive the symptoms, you must consult with a doctor specializing in dermatology. A. If abnormal symptoms such as red spots, swelling, itchiness and/or irritation occur. B. If the applied experience the above symptoms due to direct sunlight. 2. Do not use on areas with various wounds, eczema and/or dermatitis those who are sensitive to adhesive band-aids or poultice must take caution when using it. Keep away from your eyes and be sure to clean it immediately if it ever gets into an eye. 3. Safety cautions in storage and handling. A. Use immediately after you open the product. B. Do not store in high or low temperature locations and areas exposed to direct sunlight. C. Do not reuse a product that has already been used before. Keep out of reach of children. Keep away from the hands of infants and children.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. Keep away from the hands of infants and children.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indications & usage: A sufficient amount of the product is evenly applied and spread on the skin.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69783-030-012020-01-31C16284748780-19d75b9d0-c9d6-f424-e053-dadaa90a57ce1bdb079e-60fd-44c8-8a56-968348868b81

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69783-030-01Dr Cellinme Skin Care Ampoule20 in 1 CARTONSOLUTION201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69783-030DR CELLINME SKIN CARE AMPOULE (NIACINAMIDE) SOLUTION [DR.GENE CO.,LTD]1Legacy NDC, 1 package rows20150728_1bdb079e-60fd-44c8-8a56-968348868b81.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NiacinamideACTIVE INGREDIENT25X51I8RD41
NIACINAMIDEACTIVE MOIETY25X51I8RD41
METHYLPROPANEDIOLINACTIVE INGREDIENTN8F53B3R4R1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
69783-03069783-030-01

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
Niacinamide25X51I8RD4ACTIB
WATER059QF0KO0RIACT
METHYLPROPANEDIOLN8F53B3R4RIACT

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
d7021eb3-7c92-4b3c-a559-873f55c536d51bdb079e-60fd-44c8-8a56-968348868b812015-07-28WarningsExact identifier
spl id: d7021eb3-7c92-4b3c-a559-873f55c536d5
spl set id: 1bdb079e-60fd-44c8-8a56-968348868b81

Reported adverse events (FAERS/openFDA)#

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