DR CELLINME SKIN CARE AMPOULE- niacinamide solution 
Dr.Gene Co.,Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active Ingredient: Niacinamide 2.0%

INACTIVE INGREDIENT

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

Purpose: Skin Protectant

WARNINGS

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

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

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

DR CELLINME SKIN CARE AMPOULE 
niacinamide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69783-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide0.1 mg  in 20 
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69783-030-0120 in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2015
Labeler - Dr.Gene Co.,Ltd (688460085)
Registrant - Dr.Gene Co.,Ltd (688460085)
Establishment
NameAddressID/FEIBusiness Operations
Dr.Gene Co.,Ltd688460085manufacture(69783-030)

Revised: 7/2015
Document Id: d7021eb3-7c92-4b3c-a559-873f55c536d5
Set id: 1bdb079e-60fd-44c8-8a56-968348868b81
Version: 1
Effective Time: 20150728
 
Dr.Gene Co.,Ltd