NDC | 70541-030-01, 70541-030-02 |
Set ID | 2cbdb03a-0e8b-4063-a53e-9d1ec7821812 |
Category | HUMAN OTC DRUG LABEL |
Packager | Dongkook Pharmaceutical Co., Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Dipropylene Glycol, Caprylic/Capric Triglyceride, Alcohol Denat., Cetearyl Alcohol, Glyceryl Stearate, Dimethicone, Hydroxyacetophenone, Cyclopentasiloxane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cyclohexasiloxane, Xanthan Gum, Allantoin, Caffeine, Tromethamine, Caprylyl Glycol, Ethylhexylglycerin, Adenosine, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Asiaticoside, Madecassic Acid, Butylene Glycol, Asiatic Acid, Olea Europaea (Olive) Fruit Oil, Pelargonium Graveolens Flower Oil, Citrus Aurantium Dulcis (Orange) Oil, Citrus Grandis (Grapefruit) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Cananga Odorata Flower Oil, Cedrus Atlantica Bark Oil, Phenoxyethanol, Althaea Rosea Flower Extract, Rosa Damascena Flower Oil, Aqua, Copaifera Officinalis (Balsam Copaiba) Resin, Jasminum Officinale (Jasmine) Oil, Centella Asiatica Leaf Extract, Saccharide Isomerate, Artemisia Absinthium Extract, Rose Flower Oil, Xylitylglucoside, Anhydroxylitol, Propanediol, Ferula Galbaniflua (Galbanum) Resin Oil, Pseudoalteromonas Ferment Extract, Thuja Occidentalis Leaf Oil, Xylitol, Hydrolyzed Rice Protein, Algae Extract, Magnesium Aspartate, Zinc Gluconate, Glutamic Acid, Glycoproteins, Sodium Benzoate, Asparagus Officinalis Stem Extract, Cladosiphon Novae-Caledoniae Extract, Potassium Sorbate, Citric Acid, Copper Gluconate, Glycine Soja (Soybean) Protein, Superoxide Dismutase, Threonine, Valine, Calcium Gluconate, Gluconolactone Sodium Citrate, Alanine, Palmitoyl Tripeptide-5, Proline, Serine, Sodium Phosphate, Acetyl Hexapeptide-8, Sodium Dextran Sulfate, Sodium Metabisulfite, Sodium Hydroxide
- PURPOSE
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WARNINGS
Warnings: 1. Avoid contact with eyes. In case of contact with eyes, rinse immediately with water. 2. Use with caution if you are highly sensitive to any bandages or wet compresses. 3. Do not use the product on an open skin wound or on areas of eczema or infection. 4. If any signs of the following skin troubles appear, discontinue use and talk to your dermatologist as it may aggravate the condition. 1) If any conditions such as rash, swelling, itching, or irritation occur when using the product. 2) If sunlight exposure to an area of skin to which the product is applied causes skin irritation as above. 5. Storage and handling instructions 1) Apply immediately after removing it from packaging because it can dry up. 2) Keep out of reach of children. 3) Avoid exposure to high or low temperatures or sun.
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Indications & usage: 1. After cleansing your face, apply skin toner. 2. Take the product out of the package and adhere it evenly over your face avoiding the eye and mouth area. 3. Remove it after 10-20 minutes. Using your fingers, gently pat any remaining product into the skin until thoroughly absorbed.
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MADECA DERMA MASK II
glycerin, niacinamide patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70541-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1.25 g in 25 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 0.5 g in 25 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70541-030-02 10 in 1 CARTON 05/01/2016 07/12/2020 1 NDC:70541-030-01 25 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/2016 07/12/2020 Labeler - Dongkook Pharmaceutical Co., Ltd. (688003495) Registrant - Dongkook Pharmaceutical Co., Ltd. (688003495) Establishment Name Address ID/FEI Business Operations Dongkook Pharmaceutical Co., Ltd. 688003495 manufacture(70541-030)