Label: KARATICA I M CURE- niacinamide patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 December 4, 2018

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  • ACTIVE INGREDIENT

    niacinamide

  • INACTIVE INGREDIENT

    SodiumHyaluronate, Niacinamide, CamelliaJaponicaFlowerExtract, CentellaAsiaticaExtract, Tranexamicacid, SalicylicAcid, TetraPeptide-44, Sh-Oligopepide-1, Sh-Polypepide-1

  • PURPOSE

    skin soothing and care

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children

  • INDICATIONS & USAGE

    Clean and dry the face. Apply the patch on the troubled area and press it gently for 10 seconds. Leave the patch on for 2‒3 hours.

    * The Essence Chip (micro projections) must be kept dry.

  • WARNINGS

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

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

    3) Cautions for the storage and handling.

    - Keep out of children.

    - Avoid applying around eyes.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    KARATICA I M CURE 
    niacinamide patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70514-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2.7 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70514-0012-16 in 1 PACKAGE12/05/2018
    15 mg in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/05/2018
    Labeler - Karatica Co., Ltd (689605545)
    Registrant - Karatica Co., Ltd (689605545)
    Establishment
    NameAddressID/FEIBusiness Operations
    Karatica Co., Ltd689605545manufacture(70514-0012) , label(70514-0012) , pack(70514-0012)