Label: REFINING PORE CLEAR PACK- glycerin gel

  • 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 February 24, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Glycerin 10.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Kaolin, Lavandula Angustifolia (Lavender) Flower Extract, Glycerin, Bentonite, Prunus Armeniaca (Apricot) Kernel Oil, Camellia Japonica Seed Oil, Macadamia Integrifolia Seed Oil, Betaine, Cetearyl Alcohol, Cetearyl Glucoside, Carbomer, Arginine, Sodium Hyaluronate, Glyceryl Stearate, PEG-100 Stearate, Soluble Collagen, Lonicera Japonica (Honeysuckle) Flower Extract, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Rosa Centifolia Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Jasminum Officinale (Jasmine) Extract, Rosa Canina Fruit Extract, Hibiscus Sabdariffa Flower Extract, Citrus Unshiu Peel Extract, Saururus Chinensis Extract, Houttuynia Cordata Extract, Castanea Crenata (Chestnut) Shell Extract, Salicornia Herbacea Extract, Niacinamide, Panthenol, Allantoin, Xanthan Gum, Disodium EDTA, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:

    1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight 4. Be aware not to get into eyes.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Usage

    Usage: Once applying thickly it on the face, wash the face with warm water for 10 ~ 20 minutes. It would be good to have it 2 ~ 3 times a week.

  • Usage

    Usage: Once applying thickly it on the face, wash the face with warm water for 10 ~ 20 minutes. It would be good to have it 2 ~ 3 times a week.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    REFINING PORE CLEAR PACK 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70380-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin15 g  in 150 g
    Inactive Ingredients
    Ingredient NameStrength
    Kaolin (UNII: 24H4NWX5CO)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70380-300-01150 g in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/02/2016
    Labeler - MIGUHARA (689204213)
    Registrant - MIGUHARA (689204213)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIGUHARA689204213manufacture(70380-300)