Fjell Mask Pack

Manufacturer
Fjell INC.
Effective date
2018-03-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:03

Label at a glance#

ProductFjell Mask Pack
Active ingredientPumice
Label structure8 sections

Indications and 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 Vita...

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Pumice 20%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Deep cleansing

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1288809235678150mask carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72194-010-022020-01-31C16284748780-19d75b9d0-24bb-f424-e053-dadaa90a57ce9de27a47-1340-496a-aa64-998b841e56bc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72194-010-01Fjell Mask Pack150 mL in 1 CONTAINERCREAM1501
72194-010-02Fjell Mask Pack1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72194-010FJELL MASK PACK (PUMICE) CREAM [FJELL INC.]1Legacy NDC, 2 package rows20180329_9de27a47-1340-496a-aa64-998b841e56bc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72194-01072194-010-01, 72194-010-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PumiceNT5NN5KL16ACTIB
Water059QF0KO0RIACT
Propylene Glycol6DC9Q167V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7c95c3c5-d856-4dbc-b346-2da7062396ab9de27a47-1340-496a-aa64-998b841e56bc2018-03-29WarningsExact identifier
spl id: 7c95c3c5-d856-4dbc-b346-2da7062396ab
spl set id: 9de27a47-1340-496a-aa64-998b841e56bc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.