Label: BY PHARMICELL LAB THE PRESTIGE- glycerin cream

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 2, 2013

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  • ACTIVE INGREDIENT

    Active ingredient : GLYCERIN 20%

  • INACTIVE INGREDIENT

    Inactive ingredients : WATER, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, BUTYLENE GLYCOL, CETYL ETHYLHEXANOATE, HYDROGENATED POLYDECENE, CETEARYL ALCOHOL, NIACINAMIDE, HYDROGENATED VEGETABLE OIL, VEGETABLE OIL, BUTYROSPERMUM PARKII(SHEA BUTTER), DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, STEARIC ACID, CETEARETH-20, DIMETHICONE, GLYCERYL STEARATE, MACADAMIA TERNIFOLIA SEED OIL, CETYL PEG/PPG-10/1 DIMETHICONE, 1,2-HEXANEDIOL, PHENOXYETHANOL, HYDROGENATED LECITHIN, XANTHAN GUM, SODIUM POLYACRYLATE, PANAX GINSENG ROOT EXTRACT, CLADOSIPHON OKAMURANUS EXTRACT, ALTHAEA ROSEA ROOT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CERAMIDE 3, NEOFINETIA FALCATA CALLUS CULTURE EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, PULSATILLA KOREANA EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, LECITHIN, DEXTRIN, POLYACRYLATE-13, POLYISOBUTENE, POLYSORBATE 20, ADENOSINE, CITRUS MEDICA LIMONUM (LEMON) FRUIT OIL, JASMINUM OFFICINALE (JASMINE) OIL, ROSA CENTIFOLIA FLOWER OIL, SODIUM HYALURONATE

  • PURPOSE

    Purpose : Skin Protectant

  • WARNINGS

    Warning : Keep out of reach of children and babies. For external use only. Avoid contact with eyes. Discontinue use if signs of irritation and/or rash appear.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and babies.

  • INDICATIONS AND USAGE

    Indications and usage : After taking the cream with a size of pea using a spatula, spread it evenly over the face and neck, and massage gently with both hands

  • DOSAGE AND ADMINISTRATION

    Dosage and administration : Take a proper amount of the product and spread it evenly over the entire face.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BY PHARMICELL LAB THE PRESTIGE 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60949-010-0150 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2013
    Labeler - Pharmicell Co., Ltd. (687744110)
    Registrant - Pharmicell Co., Ltd. (687744110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmicell Co., Ltd.687744110manufacture(60949-010)
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