Label: ESOPINIO ANIMATING WATER- 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 August 29, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Glycerin, Butylene Glycol, Glycereth-26, Alcohol, Cyclomethicone, Glyceryl, Polymethacrylate, Butylene Glycol Dicaprylate/Dicaprate, Sodium Hyaluronate, Portulaca Oleracea Extract, PEG-60 Hydrogenated Castor Oil, Dimethicone/Vinyl Dimethicone, Crosspolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Carbomer, Triethanolamine, Phenoxyethanol, Isononyl Isononanoate, Caprylic Capric Triglyceride, Dipotassium Glycyrrhizate, Hematite Extract, Topaz, Aluminum Silicate, Zeolite, Olivine Extract, Anthemis Nobilis Flower Extact, Hydroxyethylcellulose, Ceramide 3, Allantoin, Hydrogenated Lecithin, Disoium EDTA, Chaenomeles Sinensis Fruit Extract, Sea Water, Methyl Paraen, Flavor

  • PURPOSE

    Purpose:
    It makes an emolient skin by eliminating the psoriasis and itching caused by the keratose in skin.
    It prevents the evaporation by forming a film on the skin, and then it makes  skin smooth and moist by increasing the moisture constantly.
    It helps to vitalize and animate the skin by holding of the water in skin.    
    It helps to reduce the skin's irritation.    
    It helps to lessen the sensitive skin.

  • WARNINGS

    Warnings:
    In case of having following symptoms after using this, you're advised to stop using it immediately.  If you keep using it,  the  symptoms will get worse and need to consult a dermatologist.
    - In case of having problems such as red rash, swollenness, itching, stimulation during usage.
    - In case of having the same symptoms above on the part you put this product on by direct sunlight.
    You are banned to use it on the part where you have a scar, eczema, or dermatitis.
    In case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of the reach of babies and children.

  • INDICATIONS & USAGE

    Indication and usage:
    Tighten the lid after using it.
    Don't keep it in the place where the temperature is extremely hot or low and exposed the direct sunlight.
    Use it in the morning and evening after applying the Esopinio Wrinkless Plus CT-I.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Take up about 1.2g - 1.5g of it and smooth over the entire face.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ESOPINIO ANIMATING WATER 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44781-170
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone0.55 g  in 55 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    ALCOHOL (UNII: 3K9958V90M)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44781-170-0155 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2010
    Labeler - ZION SYNTHETIC FIBER CO., LTD. (688011147)
    Registrant - ZION SYNTHETIC FIBER CO., LTD. (688011147)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZION SYNTHETIC FIBER CO., LTD.688011147manufacture