Label: SIERO TURNOVER 21 CREA M PACK- 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 June 28, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Dimethicone 4.0%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Glycerin, Dipropylene Glycol, Butylene Glycol, Stearic Acid, Isopropyl Myristate, Cetyl Alcohol, Gluconolactone, Glyceryl Stearate, PEG-100 Stearate, Glyceryl Stearate SE, Portulaca Oleracea Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Phenoxyethanol, Carbomer, Chlorphenesin, Potassium Hydroxide, Lactobionic Acid, Citrus Aurantium Dulcis (Orange) Oil, t-Butyl Alcohol, Citrus Aurantifolia (Lime) Oil, Citrus Grandis (Grapefruit) Peel Oil, Disodium EDTA, Citrus Limon (Lemon) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens Flower Oil, Ocimum Basilicum (Basil) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Salvia Sclarea (Clary) Oil

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: - Keep away from direct sunlight and high temperature. - Use only at night. - For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses: A home peeling cream pack that makes your skin that is dry and flaky from dead skin smooth and moisturized while sleeping pH 4.2 mildly acidic sleeping cream pack contains gluconolactone, a type of PHA, and lactobionic acid to take care of the dead skin cells gently at night by shortening their turnover cycle to 21 days for a healthy and smooth skin texture.

  • Directions

    Directions: Before going to bed, apply to the entire face as the last step of skin care and let it absorb. (Do not use during the day.)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SIERO TURNOVER 21 CREA M PACK 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71472-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone2.0 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71472-010-021 in 1 CARTON06/01/2017
    1NDC:71472-010-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2017
    Labeler - JNG KOREA CO.,LTD. (557796103)
    Registrant - JNG KOREA CO.,LTD. (557796103)
    Establishment
    NameAddressID/FEIBusiness Operations
    JNG KOREA CO.,LTD.557796103relabel(71472-010)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(71472-010)
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