Label: SIERO VANISH OI L POWDE R PACT- dimethicone powder

  • 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 30, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: DIMETHICONE 1.05%

  • INACTIVE INGREDIENT

    Inactive ingredients: TALC, POLYMETHYL METHACRYLATE,HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, POLYETHYLENE, SILICA, 1,2-HEXANEDIOL, TRIETHOXYCAPRYLYLSILANE, GLYCERYL CAPRYLATE, WATER, BUTYLENE GLYCOL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF EXTRACT, PHENOXYETHANOL, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER/LEAF/STEM EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT, ETHYLHEXYLGLYCERIN

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: - Keep away from direct sunlight and high temperature. - 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: Light powder pact without being cakey, even with several applications Ultra-light touch powder is adheres tightly to cover skin flaws, such as pores and sebum, and provide a fresh finish without cakiness, even with several applications. Cares for sweat and sebum, and the reduced oil content makes it possible to use every day with the light feeling of a powder.

  • Directions

    Directions: Take a moderate amount using a puff and spread it over the entire face with a light dab.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SIERO VANISH OI L POWDE R PACT 
    dimethicone powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71472-260
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.05 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71472-260-021 in 1 CARTON06/01/2017
    1NDC:71472-260-0110 g in 1 CONTAINER; 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(71472-260)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689847167manufacture(71472-260)
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