Label: QUEENS ROSE ELYSEE ESSENCE EYE- dimethicone 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 March 24, 2017

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

  • ACTIVE INGREDIENT

    Active ingredients: Dimethicone 2.50%

  • INACTIVE INGREDIENT

    Inactive ingredients: Rosa Damascena Flower Water, Water, Glycerin, Butylene Glycol, Cetyl Ethylhexanoate, Dicaprylyl Carbonate, Pentaerythrityl Tetraethylhexanoate, Cetearyl Alcohol, Polyglyceryl-3 Methylglucose Distearate, Glyceryl Stearate, Niacinamide, Squalane, 1,2-Hexanediol, Cocos Nucifera (Coconut) Oil, PEG-100 Stearate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Ceramide NP, Polyacrylate-13, Human Stem Cell Conditioned Media, Phenoxyethanol, Caprylyl Glycol, Polyisobutene, Phospholipids,Phytosphingosine, Copernicia Cerifera (Carnauba) Wax, Fragrance(Parfum), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Nelumbo Nucifera Flower Extract, Prunus Mume Fruit Extract, Eclipta Prostrata Extract, Tromethamine, Macadamia Ternifolia Seed Oil, Ethylhexylglycerin, Adenosine, Polysorbate 20, Dipotassium Glycyrrhizate, Disodium EDTA, Sorbitan Isostearate, Melia Azadirachta Leaf Extract, Phytosterols, Melia Azadirachta Flower Extract, Curcuma Longa (Turmeric) Root Extract, Ocimum Sanctum Leaf Extract, Moringa Oleifera Seed Oil, Corallina Officinalis Extract, Tropolone

  • PURPOSE

    Purpose: Skin Protectant

  • 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

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & Usage: Helps prevent and relieve chapped or cracked skin.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: - Take a proper amount of product, and spread it evenly over the entire face. - Apply in daily skin care routine.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    QUEENS ROSE ELYSEE ESSENCE EYE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71252-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.25 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71252-070-021 in 1 CARTON03/02/2017
    1NDC:71252-070-0150 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/02/2017
    Labeler - Cdpharmtec Co.,ltd (694209262)
    Registrant - Cdpharmtec Co.,ltd (694209262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cdpharmtec Co.,ltd694209262relabel(71252-070)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc689049693manufacture(71252-070)