Label: BY PHARMICELL LAB THE PRESTIGE ESSENCE- allantoin 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 November 19, 2013

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  • ACTIVE INGREDIENT

    Active ingredient : ALLANTOIN 0.5%

  • INACTIVE INGREDIENT

    Inactive ingredient : WATER, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, GLYCERIN, DIPROPYLENE GLYCOL, HYDROGENATED POLYDECENE, NEOPENTYL GLYCOL DICAPRATE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, GLYCERYL STEARATE SE, HYDROGENATED LECITHIN, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, BEESWAX, POLYGONUM MULTIFLORUM ROOT EXTRACT, ACANTHOPANAX SENTICOSUS (ELEUTHERO) ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, PANAX GINSENG ROOT EXTRACT, ASPARAGUS COCHINCHINENSIS ROOT EXTRACT, HYDROGENATED LECITHIN, TOCOPHERYL ACETATE, CARBOMER, PHENOXYETHANOL, 1,2-HEXANEDIOL, XANTHAN GUM, POTASSIUM HYDROXIDE, LITHOSPERMUM ERYTHRORHIZON ROOT OIL, DIPOTASSIUM GLYCYRRHIZATE, ALTHAEA ROSEA ROOT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, CLADOSIPHON OKAMURANUS EXTRACT, CERAMIDE 3, NEOFINETIA FALCATA CALLUS CULTURE EXTRACT, ZANTHOXYLUM PIPERITUM FRUIT EXTRACT, PULSATILLA KOREANA EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, LECITHIN, ADENOSINE, SODIUM HYALURONATE, DEXTRIN, 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

  • 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 pumping a proper amount of the essence, spread it evenly along the lines of the face for sufficient absorption.

  • 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 ESSENCE 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.22 mg  in 45 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60949-020-0145 mL 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(60949-020)
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