Label: LUXURY CELL PERFORMANCE- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 September 22, 2014

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  • ACTIVE INGREDIENT

    Active ingredient : DIMETHICONE 1%

  • INACTIVE INGREDIENT

    Inactive ingredients : WATER, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, DIPROPYLENE GLYCOL, BUTYLENE GLYCOL, GLYCERIN, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, CETEARYL ALCOHOL, NEOPENTYL GLYCOL DICAPRATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ETHYLHEXANOATE, BETAINE, BUTYROSPERMUM PARKII(SHEA BUTTER),
    STEARIC ACID, GLYCERYL STEARATE SE, PEG-40 STEARATE, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, BEESWAX, POLYGONUM MULTIFLORUM ROOT EXTRACT, ARTEMISIA PRINCEPS LEAF EXTRACT, PORTULACA OLERACEA EXTRACT, PANAX GINSENG ROOT EXTRACT, ASPARAGUS COCHINCHINENSIS ROOT EXTRACT, 1,2-HEXANEDIOL, CARBOMER, PHENOXYETHANOL, CETEARETH-20, HYDROGENATED LECITHIN, GLYCERYL STEARATE, SORBITAN STEARATE, XANTHAN GUM, POTASSIUM HYDROXIDE, DIPOTASSIUM GLYCYRRHIZATE, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, GRIFOLA FRONDOSA EXTRACT, INONOTUS OBLIQUUS (MUSHROOM) EXTRACT, SPARASSIS CRISPA EXTRACT, PHELLINUS LINTEUS EXTRACT, ALTHAEA ROSEA ROOT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, POLYACRYLATE-13, POLYISOBUTENE, POLYSORBATE 20, CERAMIDE 3, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, EUCALYPTUS GLOBULUS LEAF OIL, GERANIUM MACULATUM OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, MENTHA PIPERITA (PEPPERMINT)OIL, ADENOSINE, SODIUM HYALURONATE

  • PURPOSE

    Purpose : Skin Protectant

  • WARNINGS

    Warnings : Harmful if swallowed. Avoid contact with the eyes. Keep out of reach of children. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indication and usage : At the last step of skin care, take the cream with a size of pea using a spatula, and spread it evenly over the face and neck, and press the face lightly with both hands.

  • DOSAGE & 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
    LUXURY CELL PERFORMANCE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.5 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60949-160-0150 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2014
    Labeler - Pharmicell Co., Ltd. (687744110)
    Registrant - Pharmicell Co., Ltd. (687744110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmicell Co., Ltd.687744110manufacture(60949-160)
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