Label: PEARSYS- sodium hyaluronate kit

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 21, 2019

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  • ACTIVE INGREDIENT

    Sodium hyaluronate

  • INACTIVE INGREDIENT

    - roller

    Water
    Human Fibroblast Conditioned Media
    1,2-Hexanediol
    Niacinamide
    Sodium Hyaluronate
    sh-Pentapeptide-19
    sh-Octapeptide-4
    Leontopodium Alpinum Callus Culture Extract
    Ethylhexylglycerin
    Glutathione
    Galloyl Pentapeptide-33
    Glycine
    Glutamine
    Isoleucine
    Leucine
    Methionine
    Phenylalanine
    Serine
    Threonine
    Tryptophan
    Valine
    Folic Acid
    Riboflavin
    Thiamine HCl
    Calcium Chloride
    Magnesium Sulfate
    Potassium Chloride
    Sodium Pyruvate
    Cysteine
    Arginine
    Lysine
    Proline
    Adenosine
    Glycosyl Trehalose
    Hydrogenated Starch Hydrolysate
    Tromethamine
    Citric Acid
    Hydrolyzed F-Fucoidan

    - patch

    Water
    Acetyl hexapeptide-8 Water
    Caprylyl glycol
    Acetyl hexapeptide-8
    Sodium hyaluronate
    Cellulose gum
    Lactose
    Glycerin
    Marigold Extract HD Water
    Calendula officinalis flower extract
    1,2-Hexanediol
    Licorice Extract HD Water
    Glycyrrhiza uralensis (licorice) root extract
    1,2-Hexanediol
    GH-815 Propanediol
    Caprylyl glycol
    Ethylhexyl glycerin
    Madecassoside

  • PURPOSE

    DMS (Dissolving Micro Structure) Technology Microchip gives minute skin stimulation to help skin concentrate and absorb active ingredients

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    spread water soluble cosmetics all over your face before using

    open one sterilized micro chip roller for use

    press the left pushbutton of the dedicated roller handle to insert a micro chip roller

    gently rolls massages along the fact surface from inside to outside

    use only until you feel no stimulation from the micro chip

    after using, apply cosmetics evenly across face

    after using, press the roller handle depressor to discard the micro chip roller (the micro chip roller is disposable)

    dedicated roller handle keeps it clean with a continous use product

    (this product is recommended to use one every 2 to 3 days)

  • WARNINGS

    Use it for your own use only.

    For external use only.

    Discontinue use if adverse reaction occurs.

    Contact a physician if symptoms persist.

    Store at room temperature

    .Do not reuse it as a disposable product.

    Please use it immediately after opening.

  • DOSAGE & ADMINISTRATION

    for topical use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PEARSYS 
    sodium hyaluronate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72945-0004
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72945-0004-11 in 1 BOX; Type 0: Not a Combination Product07/21/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 PATCH 180 mL
    Part 21 BOTTLE, GLASS 3.3 mL
    Part 1 of 2
    PEARSYS 
    sodium hyaluronate patch
    Product Information
    Item Code (Source)NDC:72945-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM6.14 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72945-0005-145 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/26/2019
    Part 2 of 2
    AMPLE 
    sodium hyaluronate liquid
    Product Information
    Item Code (Source)NDC:72945-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM0.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ADENOSINE (UNII: K72T3FS567)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72945-0006-13.3 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/21/2019
    Labeler - J World (690082781)
    Registrant - J World (690082781)
    Establishment
    NameAddressID/FEIBusiness Operations
    J World690082781manufacture(72945-0004) , label(72945-0004)
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