Label: DR CELLINME SKIN CARE AMPOULE- niacinamide solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated July 28, 2015

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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

  • INGREDIENTS AND APPEARANCE
    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)