Madeca

Manufacturer
Dongkook Pharmaceutical Co., Ltd.
Effective date
2018-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:39:06

Label at a glance#

ProductMadeca
Active ingredientGLYCERIN, NIACINAMIDE
Label structure8 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Glycerin 2.0%, Niacinamide 2.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Directions

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70541-02070541-020-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
7e078789-a33b-3fd1-e053-2991aa0af327d8f99662-cbbd-4f67-bc61-582ef442c8a62018-12-27WarningsExact identifier
spl id: 7e078789-a33b-3fd1-e053-2991aa0af327
spl set id: d8f99662-cbbd-4f67-bc61-582ef442c8a6

Reported adverse events (FAERS/openFDA)#

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