Label: PANDAS DREAM SO COOL EYE SERUM- dimethicone stick

  • 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 16, 2016

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  • ACTIVE INGREDIENT

    Active ingredient: Dimethicone 1.0%

  • INACTIVE INGREDIENT

    Inactive Ingredient: Water, Butylene Glycol, Sodium Stearate, Alcohol, Xylitol, PEG-12 Dimethicone, Glycerin, PEG-8, Bis-PEG-18 Methyl Ether Dimethyl Silane, Niacinamide, Sodium Citrate, Potassium Alginate, Methyl Methacrylate Crosspolymer, Xanthan Gum, Phenoxyethanol, Citric Acid, Actinidia Arguta Fruit Extract, Sea Water, Bambusa Vulgaris Shoot Extract, Bambusa Vulgaris Sap Extract, Glacier Water, Fragrance, Adenosine, Steareth-20, Caprylyl Glycol, 1,2-Hexanediol, CI 42090, Caprylhydroxamic Acid, N-Hydroxysuccinimide, Chlorhexidine Digluconate, Potassium Sorbate, Chrysin, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Tropolone

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only When using this product do not get into eyes Stop use and ask a doctor if rash occurs Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Use

    Use: Helps prevent and relieve chapped or cracked skin

  • Directions

    Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PANDAS DREAM SO COOL EYE SERUM 
    dimethicone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-314
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.09 g  in 9 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-314-021 in 1 CARTON05/01/2016
    1NDC:59078-314-019 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/2016
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO.,LTD688216798manufacture(59078-314)
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