Label: BY PHARMICELL LAB LUXURY CELL PERFORMANCE EMULSION- 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 July 7, 2013

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  • ACTIVE INGREDIENT

    Active ingredient : ALLANTOIN 0.5%

  • INACTIVE INGREDIENT

    Inactive ingredient : WATER, HYDROGENATED POLYDECENE, BUTYLENE GLYCOL, GLYCERIN, TRIETHYLHEXANOIN, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, BEHENYL ALCOHOL, GLYCERYL STEARATE, PEG-100 STEARATE, BEHENIC ACID, ISOSTEARIC ACID, STEARIC ACID, HYDROGENATED LECITHIN, POLYGONUM MULTIFLORUM ROOT EXTRACT, ACANTHOPANAX SENTICOSUS (ELEUTHERO) ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, PANAX GINSENG ROOT EXTRACT, ASPARAGUS COCHINCHINENSIS ROOT EXTRACT, 1,2-HEXANEDIOL, CARBOMER, PHENOXYETHANOL, PEG-5 GLYCERYL STEARATE, GLYCERYL STEARATE SE, POTASSIUM HYDROXIDE, ALTHAEA ROSEA ROOT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, GRIFOLA FRONDOSA EXTRACT, INONOTUS OBLIQUUS (MUSHROOM) EXTRACT, SPARASSIS CRISPA EXTRACT, PHELLINUS LINTEUS EXTRACT , CERAMIDE 3, ADENOSINE, 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 using the serum, apply the emulsion to the entire face evenly along the skin texture like massaging the entire face.

  • DOSAGE AND ADMINISTRATION

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BY PHARMICELL LAB LUXURY CELL PERFORMANCE EMULSION 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.65 mg  in 130 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60949-060-01130 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(60949-060)
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