Label: AMINO EX 500ML- salicylic acid shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 9, 2020

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  • 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, Water, , Sodium Laureth Sulfate, Calcium Oxide, Biotite, Cocamide DEA, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Decyl Glucoside, Glycerin, PEG-120 Methyl Glucose Dioleate, Polyquaternium-10, Purfume, Steartrimonium Chloride, L-Menthol, Arginine, Sulfur, Salicylic Acid, Dimethyl Sulfone, Sodium Benzoate

  • 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
    1. Keep out of reach of children
    2. Store away from direct sunlight
    • Rinse your eyes with water if they are exposed to the product.
    • Product may cause hair loss or discoloration if not rinsed out thoroughly.
    • Product is slippery. Clean it immediately if dropped on floor.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    For external use only

  • DOSAGE & ADMINISTRATION

    Thoroughly wet your hair and scalp.
    Lather a proper amount in your palms and work into your hair and scalp. Rinse out with water. Use once a day.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    AMINO EX  500ML
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71838-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71838-0010-21 in 1 CARTON06/08/2020
    1NDC:71838-0010-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H06/08/2020
    Labeler - Kwang Duk Sin Yak Co., Ltd. (688202646)
    Registrant - Kwang Duk Sin Yak Co., Ltd. (688202646)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kwang Duk Sin Yak Co., Ltd.688202646manufacture(71838-0010)
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