MADECA- glycerin, niacinamide cream

Madeca by

Drug Labeling and Warnings

Madeca by is a Otc medication manufactured, distributed, or labeled by Dongkook Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MADECA 
glycerin, niacinamide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70541-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1 g  in 50 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	1 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70541-020-01	50 mL in 1 CARTON; Type 0: Not a Combination Product	02/01/2016	07/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2016	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(70541-020)