Label: FJELL MASK PACK- pumice cream

  • 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 March 29, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: Pumice 20%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Propylene Glycol, Phellinus Linteus Extract, PEG-32, Magnesium Aluminum Silicate, Zea Mays (Corn) Starch, Alcohol, Glycosyl Trehalose, Hydrogenated Starch Hydrolysate, Sodium Hyaluronate, Ethylhexylglycerin, PEG-60 Hydrogenated Castor Oil, Caprylhydroxamic Acid, Caprylyl Glycol, Glycerin, Hydroxyethylcellulose, Fragrance, Citric Acid, Panax Ginseng Root Extract, Disodium EDTA, Niacinamide

  • PURPOSE

    Purpose: Deep cleansing

  • WARNINGS

    Warnings: Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:

    1. Pozzolana combined with germanium, selenium and authentic Korean mountain ginseng, in oder to deliver age-fighting antioxidants and stimulate collagen.

    2. When activated, our purifying ash eliminates demodex(face mites) and dead skin cells that cause aging and various skin troubles.

    3. Germanium, often called "edible oxygen" reinforces cell immunity and restores health balance. Selenium is similar to Vitamin E by safeguarding cell membranes and preventing the formation of wrinkles.

    4. Authentic Korean mountain ginseng provides an unmatched level of nutrients, skin firmness, elasticity and moisture retention.

    5. Liquid may come out during use of the product, but this is nutritious components of the product so it is safe for use.

  • Directions

    Directions:

    For best results, clean and dry skin before use. Test on a small area for allergies before use. Discontinue if irritation occurs. Apply a thick layer of the mask onto the face and neck avoiding the delicate eye area. Let the mask sit for 20~30 minutes depending on your skin type. Thoroughly rinse with warm water.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    FJELL MASK PACK 
    pumice cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72194-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pumice (UNII: NT5NN5KL16) (Pumice - UNII:NT5NN5KL16) Pumice30.0 g  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72194-010-021 in 1 CARTON03/01/2018
    1NDC:72194-010-01150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2018
    Labeler - Fjell INC. (694894535)
    Registrant - Fjell INC. (694894535)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fjell INC.694894535manufacture(72194-010)