DOCTOR LEAD M 500ML- salicylic acid shampoo 
Kwang Duk Sin Yak Co., Ltd.

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.

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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

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)

Revised: 2/2019
Document Id: 32cc8fd5-7a5f-4db5-b4c1-063fc43946c4
Set id: 5161800b-e0a7-489f-8268-42c053b6e1b0
Version: 1
Effective Time: 20190220
 
Kwang Duk Sin Yak Co., Ltd.