DR CELLINME SKIN CARE AMPOULE- niacinamide solution

Dr Cellinme Skin Care Ampoule by

Drug Labeling and Warnings

Dr Cellinme Skin Care Ampoule by is a Otc medication manufactured, distributed, or labeled by Dr.Gene Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DR CELLINME SKIN CARE AMPOULE 
niacinamide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69783-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	0.1 mg  in 20

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69783-030-01	20 in 1 CARTON; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2015

Labeler - Dr.Gene Co.,Ltd (688460085)

Registrant - Dr.Gene Co.,Ltd (688460085)

Establishment
Name	Address	ID/FEI	Business Operations
Dr.Gene Co.,Ltd		688460085	manufacture(69783-030)