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Madeca

Medically reviewed on April 2, 2018

Dosage form: cream
Ingredients: Glycerin 1.0g in 50mL, Niacinamide 1.0g in 50mL
Labeler: Dongkook Pharmaceutical Co., Ltd.
NDC Code: 70541-020

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.

ACTIVE INGREDIENT

Active Ingredient: Glycerin 2.0%, Niacinamide 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Centella Asiatica Leaf Water, Butylene Glycol, Squalane, Alcohol Denat., Butyrospermum Parkii (Shea) Butter, Hydrogenated Poly(C6-14 Olefin), Glyceryl Stearate, Macadamia Integrifolia Seed Oil, Caprylic/Capric/Myristic/Stearic Triglyceride, Caprylic/Capric Triglyceride, Cetearyl Alcohol, PEG-40 Stearate, Cyclopentasiloxane, Pentylene Glycol, Synthetic Beeswax, Cyclohexasiloxane, PEG-100 Stearate, Polyacrylate-13, Cetyl PEG/PPG-10/1 Dimethicone, Stearic Acid, PEG-30 Dipolyhydroxystearate, Phenoxyethanol, Asiaticoside, Madecassic Acid, Asiatic Acid, Polyisobutene, Caprylyl Glycol, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Polysorbate 20, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Adenosine, Disodium EDTA, 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, Rosa Damascena Flower Oil, Raspberry Seed Oil/Tocopheryl Succinate Aminopropanediol Esters, Polydecene, Dipropylene Glycol, Copaifera Officinalis (Balsam Copaiba) Resin, Jasminum Officinale (Jasmine) Oil, Imperata Cylindrica Root Extract, Sodium Palmitoyl Proline, Artemisia Absinthium Extract, Rose Flower Oil, Camellia Japonica Flower Extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Ferula Galbaniflua (Galbanum) Resin Oil, Thuja Occidentalis Leaf Oil, Nymphaea Alba Flower Extract, PEG-8, Carpinus Tschonoskii Leaf Extract, Viscum Album (Mistletoe) Fruit Extract, Melissa Officinalis Leaf Extract, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Veronica Officinalis Extract, Sodium Polyacrylate, Hedera Helix (Ivy) Leaf/Stem Extract, Nelumbo Nucifera Flower Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Carbomer, Thermus Thermophillus Ferment, Phytic Acid, PPG-1-PEG-9 Lauryl Glycol Ether, Helianthus Annuus (Sunflower) Seed Extract, Morus Bombycis Wood Extract, Lavandula Angustifolia (Lavender) Flower Water, Rosmarinus Officinalis (Rosemary) Leaf Water, Lilium Candidum Bulb Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Rose Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Monarda Didyma Leaf Extract

PURPOSE

Purpose: Skin Protectant

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

KEEP OUT OF REACH OF CHILDREN

Directions

Directions: Softly apply cream along the skin texture and pat gently for better absorption.

Directions

Directions: Softly apply cream along the skin texture and pat gently for better absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MADECA 
glycerin, niacinamide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70541-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (GLYCERIN) Glycerin1.0 g  in 50 mL
Niacinamide (NIACINAMIDE) Niacinamide1.0 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
CENTELLA ASIATICA LEAF 
Butylene Glycol 
Packaging
#Item CodePackage Description
1NDC:70541-020-0150 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2016
Labeler - Dongkook Pharmaceutical Co., Ltd. (688003495)
Registrant - Dongkook Pharmaceutical Co., Ltd. (688003495)
Establishment
NameAddressID/FEIOperations
Dongkook Pharmaceutical Co., Ltd.688003495manufacture(70541-020)

 
Dongkook Pharmaceutical Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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