Label: CLAPIEL REVITAL SERUM- 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 July 24, 2015

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

  • ACTIVE INGREDIENT

    Active Ingredient: Dimethicone 20.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Cyclopentasiloxane, Squalane, Simmondsia Chinensis (Jojoba) Seed Oil, Cyclohexasiloxane, Linum Usitatissimum (Linseed) Seed Oil, Camellia Japonica Seed Oil, Macadamia Ternifolia Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Pichia Anomala Extract, Yeast Extract, Myrothamnus Flabellifolia Callus Culture Extract, Pentylene Glycol, Hydrolyzed Myrtus Communis Leaf Extract, Undaria Pinnatifida Extract, Lactuca Indica Extract, Corydalis Ochotensis Extract, Draba Nemorosa Extract, Chenopodium Album Flower Extract, Lactobacillus/Soybean Ferment Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Scultellaria Baicalensis Root Extract, Portulaca Oleracea Extract

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: 1. 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. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. 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 babies and children

  • INDICATIONS & USAGE

    Indications & Usage: Apply a desired amount evenly over entire face.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Take an adequate amount of this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CLAPIEL REVITAL SERUM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69977-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone6.0 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Squalane (UNII: GW89575KF9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69977-040-0130 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/2015
    Labeler - AUS KOREA CO., LTD. (689515251)
    Registrant - AUS KOREA CO., LTD. (689515251)
    Establishment
    NameAddressID/FEIBusiness Operations
    AUS KOREA CO., LTD.689515251manufacture(69977-040)