FJELL MASK PACK- pumice cream 
Fjell INC.

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.

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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

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)

Revised: 3/2018
Document Id: 7c95c3c5-d856-4dbc-b346-2da7062396ab
Set id: 9de27a47-1340-496a-aa64-998b841e56bc
Version: 1
Effective Time: 20180329
 
Fjell INC.