Amino Ex Hair Tonic
FDA Label NDC 71838-0011

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kwang Duk Sin Yak Co., Ltd. for the product Amino Ex Hair Tonic (NDC 71838-0011). 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 otc - active ingredient, inactive ingredient, otc - purpose, warnings, otc - 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

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

Label (Label)

Label (Label)

* Please review the disclaimer below.