Label: KARATICA IM CICA ESSENCE PACK- madecassoside, asiaticoside, madecassic acid, asiatic acid liquid

  • 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 August 16, 2019

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  • ACTIVE INGREDIENT

    Madecassoside, Asiaticoside, Madecassic Acid, Asiatic Acid

  • INACTIVE INGREDIENT

    Water
    MethylPerfluoroisobutylEther
    Glycerin
    ButyleneGlycol
    Caprylic/CapricTriglyceride
    ButyleneGlycolDicaprylate/Dicaprate
    Cyclopentasiloxane
    CetearylAlcohol
    Coco-glucoside
    Cyclohexasiloxane
    GlycerylStearate
    PEG-100 Stearate
    PalmiticAcid
    AmmoniumAcryloyldimethyltaurate/VP Copolymer
    StearicAcid
    SodiumLauroylGlutamate
    HydrogenatedLecithin
    CoptisJaponicaExtract
    Propanediol
    HydrolyzedPeaProtein
    Prunus Amygdalus Dulcis (Sweet Almond) Shell Powder
    Carbomer 940
    Arginine
    Betaine
    ButyrospermumParkii (Shea) Butter
    Ceramide NP
    Melaleuca Alternifolia (Tea Tree) Leaf Water
    Chlorophyllin-Copper Complex
    CitricAcid
    BetaineSalicylate
    Gluconolactone
    XanthanGum
    HydrogenatedPolydecene
    LauricAcid
    MyristicAcid
    SucroseStearate
    Phytosterol
    HydrogenatedPhosphatidylcholine
    Lecithin
    Olea Europaea (Olive) Fruit Oil
    Squalane
    SodiumPolyacrylate
    Allantoin
    1,2-Hexanediol
    PentyleneGlycol
    Chlorphenesin
    Disodium EDTA
    Fragrance
    t-ButylAlcohol
    Trideceth-6

  • PURPOSE

    Removal of sebum and waste

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children

  • INDICATIONS & USAGE

    1.Turn on the brush and press the tube.
    2.Gently apply on face avoiding eyes and lips and wait for bubbles.
    3.When bubble forms, softly massage face with brush. Then wash off with warm water.
    4.Make sure to turn off the brush and cleanse the brush after each use.

  • WARNINGS

    1) Discontinue use or consult dermatologist if irritation, itching or swelling appears after applying the product.

    2) Avoid applying product on the wounded, inflamed skin parts.

    3) Cautions for the storage and handing

    a)Keep out of children.

    b)Avoid direct sun light

    c)Avoid applying around eyes

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    KARATICA IM CICA ESSENCE PACK 
    madecassoside, asiaticoside, madecassic acid, asiatic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70514-0013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASIATICOSIDE (UNII: PKO39VY215) (ASIATICOSIDE - UNII:PKO39VY215) ASIATICOSIDE0.01 g  in 100 mL
    MADECASSOSIDE (UNII: CQ2F5O6YIY) (MADECASSOSIDE - UNII:CQ2F5O6YIY) MADECASSOSIDE0.01 g  in 100 mL
    MADECASSIC ACID (UNII: M7O1N24J82) (MADECASSIC ACID - UNII:M7O1N24J82) MADECASSIC ACID0.01 g  in 100 mL
    ASIATIC ACID (UNII: 9PA5A687X5) (ASIATIC ACID - UNII:9PA5A687X5) ASIATIC ACID0.01 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70514-0013-1100 mL in 1 TUBE; Type 0: Not a Combination Product08/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/17/2019
    Labeler - Karatica Co., Ltd (689605545)
    Registrant - Karatica Co., Ltd (689605545)
    Establishment
    NameAddressID/FEIBusiness Operations
    Karatica Co., Ltd689605545manufacture(70514-0013) , label(70514-0013) , pack(70514-0013)