Label: QUEENS ROSE ELYSEE- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL

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

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  • ACTIVE INGREDIENT

    Active ingredients: Dimethicone 10.82%

  • INACTIVE INGREDIENT

    Inactive ingredients: Rosa Damascena Flower Water, Dipropylene Glycol, Water, Cyclopentasiloxane, PCA Dimethicone, Petrolatum, Glycerin, Cetearyl Alcohol, Butylene Glycol, Glycereth-26, Niacinamide, Trisiloxane, Dimethiconol, Glyceryl Stearate SE, Pentylene Glycol,Squalane, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Methylglucose Distearate, Ceramide NP, Ammonium Acryloyldimethyltaurate/VP Copolymer, Human Stem Cell Conditioned Media, PEG-150 Distearate, Phenoxyethanol, Phospholipids, Caprylyl Glycol,Fragrance(Parfum), Raffinose, Xanthan Gum, Phytosphingosine, Hydrogenated Lecithin, Eclipta Prostrata Extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium Glycyrrhizate,Sucrose Distearate, 1,2-Hexanediol, Nelumbo Nucifera Flower Extract, Prunus Mume Fruit Extract, Adenosine, Melia Azadirachta Leaf Extract, Phytosterols, Disodium EDTA, 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 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71252-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone5.41 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
    Dipropylene Glycol (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71252-080-021 in 1 CARTON03/02/2017
    1NDC:71252-080-0150 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(71252-080)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc689049693manufacture(71252-080)
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