Label: REPIEL SMART NAIL PACK MIRACLE BUTTER- glycerin 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 June 29, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Glycerin 11.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Mineral Oil, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Cyclohexasiloxane, Polysorbate 60, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Butylene Glycol, Glyceryl Stearate SE, Phenoxyethanol, 1.2-Hexanediol, Propanediol, Caprylyl Glycol, Illicium Verum(Anise)Fruit Extract, Behenyl Alcohol, Beeswax, Betaine, Dimethicone, Carbomer, Arginine, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limonum (Lemon) Fruit Oil, Citrus Aurantifolia (Lime) Oil, Citrus Grandis (Grapefruit) Peel Oil, Disodium EDTA, Butyrospermum Parkii (Shea Butter), Mangifera Indica (Mango) Seed Butter, Tocopheryl Acetate, Hydroxypropyltrimonium Hydrolyzed Silk, Soluble Collagen, Milk Protein Extract, Ceramide 3, Ascorbyl Tetraisopalmitate

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only 1. If the following symptoms arise upon use of the cosmetic product, immediately discontinue use and consult a dermatologist, for continued use may aggravate the symptoms. A. Redness, swelling, itchiness, stimulation, or other symptoms B. Occurrence of the above symptoms upon exposure to direct sunlight. 2. Do not use on areas with wounds, eczema, or dermatitis. 3. Caution for treatment and keeping. A. Keep it out of infants of children's reach. B. Do not store in areas with extreme heat or cold, or under direct sunlight. 4. Do not use it if you have irritation on skin around your nails.

  • KEEP OUT OF REACH OF CHILDREN

    Keep it out of infants of children's reach.

  • INDICATIONS & USAGE

    Indications & Usage: Provides high nutrients on fingernails

    How to use: 1. Cut the Nail mask sheet separately and wear for each finger. 2. While waiting for 20~30 minutes, the nails becomes glittering and get nutrition. (The fingers are free to move around, to type on notebook, to works on a smart phone while even wearing the nail mask because it fits optimally on the fingers.)

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Use twice or three times a week.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    REPIEL SMART NAIL PACK MIRACLE BUTTER 
    glycerin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70758-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin0.33 g  in 3 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70758-020-0210 in 1 CARTON05/01/2016
    1NDC:70758-020-013 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2016
    Labeler - THE COSRISE CO.,LTD (689840253)
    Registrant - THE COSRISE CO.,LTD (689840253)
    Establishment
    NameAddressID/FEIBusiness Operations
    THE COSRISE CO.,LTD689840253manufacture(70758-020)