FDA Label for Amino Ex Hair Tonic 500ml

View Indications, Usage & Precautions

Amino Ex Hair Tonic 500ml Product Label

The following document was submitted to the FDA by the labeler of this product Kwang Duk Sin Yak Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Salicylic acid 0.25%


Inactive Ingredient



Betula Platyphylla Japonica Bark/Biota Orientalis Leaf/Camellia Sinensis Leaf/EcliptaProstrata/Houttuynia Cordata/Lonicera Caprifolium (Honeysuckle)/Luffa Cylindrica Fruit/MorusAlba Fruit/Morus Alba Bark/Morus Alba Leaf/Phellodendron Amurense Bark/PortulacaOleracea/Salvia Miltiorrhiza Root/Sophora Flavescens Extract, Angelica Gigas/Boswellia Serrata/Carthamus Tinctorius (Safflower) Flower/Citrus UnshiuPeel/Cnidium Officinale Rhizome/Commiphora Myrrha Resin/Perilla Frutescens Leaf/PolygonumMultiflorum Root Extract, Glycyrrhiza Uralensis (Licorice) Root/Lespedeza Bicolor Bark/Thuja Orientalis Seed/ViscumAlbum (Mistletoe) Extract, Alcohol, Biotite, Glycerin, Polysorbate 80, PEG-60 Hydrogenated Castor Oil, Citric Acid, Sodium Benzoate, L-Menthol, Salicylic Acid, Dimethyl Sulfone, Arginine, Dexpanthenol, Sulfur, Disodium EDTA


Otc - Purpose



helps prevent recurrence of flaking and itching associated with dandruff on scalp


Warnings



  • For external use only
  • Seek medical attention if rash, inflammation, itchiness or other symptoms appear during use of the product or after exposure to direct sunlight.
  • Do not use on open wounds
  • Storage and handling precaution
    • Keep out of reach of children
    • Store away from direct sunlight
      • Do not use on children under 3 years of age.
      • Rinse your eyes with water if they are exposed to the product.
      • Those who have had allergic symptoms should consult a doctor and pharmacist before use.
      • Those who are hypersensitive to salicylic acid or have diabetes, blood circulation disorders, kidney failure, infection, redness, etc., and who are on their period, are pregnant or may be pregnant should not use it because the current symptoms are likely to worsen after use, such as hypersensitive skin or body or an abnormal skin reaction (edema, inflammation, etc.).

Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN


Indications & Usage



For external use only


Dosage & Administration



Shake the product thoroughly before use, apply an appropriate amount evenly on the scalp, and rub it with your fingers to absorb it as if massaging.


Package Label.Principal Display Panel




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