Label: BY PHARMICELL LAB MOISTURIZING FACE TONING MIST- allantoin spray

  • 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 8, 2013

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  • ACTIVE INGREDIENT

    Active ingredient : ALLANTOIN 0.5%

  • INACTIVE INGREDIENT

    Inactive ingredient : WATER(GLACIER WATER), WATER, BUTYLENE GLYCOL, GLYCERIN, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL, 1,2-HEXANEDIOL, PHENOXYETHANOL, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, GANODERMA LUCIDUM (MUSHROOM) EXTRACT, GRIFOLA FRONDOSA EXTRACT, INONOTUS OBLIQUUS (MUSHROOM) EXTRACT, SPARASSIS CRISPA EXTRACT, PHELLINUS LINTEUS EXTRACT, POLYGONUM MULTIFLORUM ROOT EXTRACT, ACANTHOPANAX SENTICOSUS (ELEUTHERO) ROOT EXTRACT, PORTULACA OLERACEA EXTRACT, PANAX GINSENG ROOT EXTRACT, ASPARAGUS COCHINCHINENSIS ROOT EXTRACT, 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, TRISODIUM EDTA

  • 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 : Before and after makeup, spray the mist frequently 10~20 cm away from the face in a dry indoor condition. This product can be used as an alternative to the toner, and shaking the product before use is not necessary as it has a compressed injection form.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration : Before and after makeup, spray the mist frequently 10~20 cm away from the face in a dry indoor condition.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BY PHARMICELL LAB MOISTURIZING FACE TONING MIST 
    allantoin spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.6 mg  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60949-100-01120 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(60949-100)
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