Label: DOCTOR LEAD M 500ML- salicylic acid shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 20, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient: Salicylic acid 0.25%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Betula Platyphylla Japonica Bark/Biota Orientalis Leaf/Camellia Sinensis Leaf/Eclipta Prostrata/Houttuynia Cordata/Lonicera Caprifolium (Honeysuckle)/Luffa Cylindrica Fruit/Morus Alba Fruit/Morus Alba Bark/Morus Alba Leaf/Phellodendron Amurense Bark/Portulaca Oleracea/Salvia Miltiorrhiza Root/Sophora Flavescens Extract, Angelica Gigas/Boswellia Serrata/Carthamus Tinctorius (Safflower) Flower/Citrus Unshiu Peel/Cnidium Officinale Rhizome/Commiphora Myrrha Resin/Perilla Frutescens Leaf/Polygonum Multiflorum Root Extract, Glycyrrhiza Uralensis (Licorice) Root/Lespedeza Bicolor Bark/Thuja Orientalis Seed/Viscum Album (Mistletoe) Extract, Water, Sodium Laureth Sulfate, Calcium Oxide, Cocamide DEA, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Decyl Glucoside, Glycerin, Steartrimonium Chloride, Arginine, Polyquaternium-10, Purfume, L-Menthol, Sulfur, Dimethyl Sulfone, Sodium Benzoate, Dexpanthenol, Citric Acid, Sodium Chloride, Disodium EDTA, Niacinamide

  • PURPOSE

    Purpose: Anti dandruff

  • WARNINGS

    Warnings:
    1. For external use only
    2. Seek medical attention if rash, inflammation, itchiness or other symptoms appear during use of the product or after exposure to direct sunlight.
    3. Do not use on open wounds
    4. Storage and handling precaution
    1) Keep out of reach of children
    2) Store away from direct sunlight
    5. Rinse your eyes with water if they are exposed to the product.
    6. Product may cause hair loss or discoloration if not rinsed out thoroughly.
    7. Product is slippery. Clean it immediately if dropped on floor.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:
    Helps alleviation of hair loss
    Helps prevent dandruff

  • Directions

    Directions:
    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.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DOCTOR LEAD M  500ML
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71838-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic acid1.25 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    BETULA PLATYPHYLLA BARK (UNII: ZF70YKN0YO)  
    PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71838-0005-21 in 1 CARTON12/01/2018
    1NDC:71838-0005-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2018
    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(71838-0005)