Label: MIZON GOOD NIGHT WHITE SLEEPING MASK- 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 23, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: DIMETHICONE 1.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: WATER, CYCLOMETHICONE, BUTYLENE GLYCOL, NIACINAMIDE, TREHALOSE, GLYCERIN, ALCOHOL, WATER (AND) SODIUM HYALURONATE, POLYSORBATE 20, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, TRIETHANOLMAINE, CARBOMER, WATER (AND) SCLEROTIUM GUM, BROUSSONETIA EXTRACT, MORUS ALBA BARK EXTRACT, PANTETHINE, PLACENTAL PROTEIN, NATTO GUM, BIOSCCHARIDE GUM-1, DISODIUM EDTA, METHYL PARABEN, PROPYL PARABEN, CI 17200, CI 42090, FRAGRANCE

  • PURPOSE

    Purpose: Skin protectant and brightening

  • WARNINGS

    Warnings: 1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms where product has been applied under direct sunlight. 2. Do not use on scarred skin or if you have dermatitis or eczema. 3. Keep the cap closed on this product. 4. Keep away from direct sunlight or heat. 5. Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & Usage: At the last stage of skin care at night, apply appropriate amount and spread evenly over the whole face, go to bed without wash-off.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Use twice or three times a week.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MIZON GOOD NIGHT WHITE SLEEPING MASK 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.8 g  in 80 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57718-100-0180 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/02/2016
    Labeler - MIZON CO., LTD. (557815570)
    Registrant - MIZON CO., LTD. (557815570)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIZON CO., LTD.557815570repack(57718-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coson Co., Ltd.689835593manufacture(57718-100)
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