Label: DR.ALTHEA PREMIUM INTENSIVE ESSENCE MASK- glycerin gel

  • 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 August 20, 2018

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  • ACTIVE INGREDIENT

    Dimethicone

  • INACTIVE INGREDIENT

    WATER, GLYCERIN, CYCLOPENTASILOXANE, METHYLPROPANEDIOL, 1,2-HEXANEDIOL, PENTAERYTHRITYL TETRAETHYLHEXANOATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, MYROTHAMNUS FLABELLIFOLIA LEAF EXTRACT, HYDROGENATED POLYISOBUTENE, BUTYLENE GLYCOL, VITIS VINIFERA (GRAPE) VINE SAP, BAMBUSA ARUDINACEA JUICE, TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT, CHITOSAN, CENTELLA ASIATICA EXTRACT, POLYGONUM CUSPIDATUM ROOT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, FRUCTAN, SODIUM HYALURONATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BIOSACCHARIDE GUM-1, POLYGLYCERYL-3 DISTEARATE, GLYCERYL STEARATE CITRATE, POLYQUATERNIUM-51, TOCOPHERYL ACETATE, PHENOXYETHANOL, FRAGRANCE

  • PURPOSE

    Dr. Althea Premium Intensive Essence Mask is a fast absorbing moisturizer that instantly hydrates the skin and improves the overall radiance. It restores elasticity and suppleness and gives a stunning glow on the face.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    [How To Use] After prepping cleansed face with a toner, apply an appropriate amount of Essence Mask on the face and gently massage it until it is fully absorbed into the skin. Considering the skin restoring cycle and for full benefits, use 3~4 pouches a week for four consecutive weeks.

  • WARNINGS

    1) If following symptoms occur after product use, stop using immediately and consult with a specialist: red spots, swelling, itchiness, and other skin irritations. 2) Avoid contact with eyes and open wounds. 3) Keep out of reach of children. 4) Do not store at high/low temperature. 5) Avoid direct sunlight.

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    DR.ALTHEA PREMIUM INTENSIVE ESSENCE MASK 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70905-0018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.27 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70905-0018-114 in 1 PACKAGE08/01/2018
    12 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2018
    Labeler - Dr. Althea (689694436)
    Registrant - Dr. Althea (689694436)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Althea689694436label(70905-0018)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAMSUNG MEDICOS. CO., LTD. Hyangnam Factory689851701manufacture(70905-0018)
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