Label: 2X FIRST ESSENCE- glycerin cream

  • NDC Code(s): 59078-311-01, 59078-311-02
  • Packager: TONYMOLY CO.,LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 15, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient: Glycerin 2.00%

    Close
  • INACTIVE INGREDIENT

    Inactive Ingredient: Hippophae Rhamnoides Fruit Extract, Water, Propanediol, Methylpropanediol, Saccharum Officinarum (Sugarcane) Extract, Chondrus Crispus Extract, Carthamus Tinctorius (Safflower) Flower Extract, Hydrogenated Polydecene, Dipropylene Glycol, Phenoxyethanol, PEG-40 Hydrogenated Castor Oil, Dimethicone, Carbomer, Caprylyl Glycol, Tromethamine, Hydrolyzed Collagen, Fragrance(Parfum), Helichrysum Italicum Flower Water, Butylene Glycol, Lecithin, Adenosine, Ethylhexylglycerin, Acacia Senegal Gum, Disodium EDTA, Xanthan Gum, 1,2-Hexanediol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ethylhexyl Methoxycinnamate, Talc, Pentylene Glycol, Yellow 11 (CI 47000), Glycolic Acid, Oenothera Biennis (Evening Primrose) Oil, Moringa Oleifera Seed Oil, Platinum Powder, Sodium Hyaluronate, Argania Spinosa Kernel Oil, Melia Azadirachta Leaf Extract, Polysorbate 80, Eclipta Prostrata Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Raspberry Seed Oil/Tocopheryl Succinate Aminopropanediol Esters, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Hydrogenated Lecithin, Hydrolyzed Myrtus Communis Leaf Extract, Ceramide 3, Pancratium Maritimum Extract

    Close
  • PURPOSE

    Purpose: Skin Protectant

    Close
  • WARNINGS

    Warnings: For external use only. When using this product do not get into eyes. Stop use and ask a doctor if rash occurs. Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children.

    Close
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    Close
  • Use

    Use: Moisturizing seaweed lotion that supplies moisture to rough and dry skin

    Close
  • Directions

    Directions: - After toner, After toner, then apply it along the skin texture. - Apply in daily skin care routine

    Close
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    2X FIRST ESSENCE 
    glycerin cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-311
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin 4.0 g  in 200 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Propanediol (UNII: 5965N8W85T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59078-311-02 1 in 1 CARTON 05/01/2016
    1 NDC:59078-311-01 200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 05/01/2016
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    Name Address ID/FEI Business Operations
    TONYMOLY CO.,LTD 688216798 manufacture(59078-311)
    Close