Active Ingredient
Active Ingredient: Zinc Pyrithione 1.0%
Medecean Seborrhea
FDA Label NDC 70540-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Innogene Co.,ltd for the product Medecean Seborrhea (NDC 70540-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Inactive Ingredients: Sodium Laureth Sulfate, Water, Ammonium Lauryl Sulfate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Dimethiconol, Cocamide DEA, Brassica Campestris (Rapeseed) Sterols, Glycol Distearate, Glycerin, Panthenol, SD Alcohol 40-B, Silicone Quaternium-1, Propylene Glycol, Salicylic Acid, Climbazole, TEA-Dodecylbenzenesulfonate, Cetearyl Alcohol, Ammonium Glycyrrhizate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Mannitol, Menthol, Zinc Gluconate, Caffeine, Polyquaternium-10, Hydrolyzed Yeast Protein, Allantoin, Niacinamide, Biotin, Pyridoxine HCL, Citric Acid, Guar Hydroxypropyltrimonium Chloride, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Hexamidine Diisethionate, Methylchloroisothiazolinone, Methylisothiazolinone
Purpose
Purpose: Antidandruff
Warnings
Warnings: 1. If the following conditions occur, you must stop using immediately. Continuous use will make the conditions worsen. Consult your dermatologist. a. Red swellings such as erythema, itchiness, or irritations. b. When directly sunlight causes the conditions mentioned above. 2. Do not apply on skin conditions such as wounds, eczema, ordermatitis. 3. Storage and Handling. a. Make sure to close the cap after use. b. Keep out of the reach of children. c. Avoid low temperature, high temperature, or direct sunlight. 4. When in eyes, wash immediately. 5. Not washing thoroughly after shampooing may cause hair loss or change in color. Make sure to wash thoroughly after use.
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Indications & Usage
Indications & Usage: Shampoo daily, massage your wel scalp and hair and leave on for 5 minutes before rinsing. BallVic Solution is recommended after you dry your hair.
Dosage & Administration
Dosage & Administration: Take 5g of this product for one use.
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