AMINO EX 500ML- salicylic acid shampoo 
Kwang Duk Sin Yak Co., Ltd.

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.

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Salicylic acid 0.25%

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

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

  1. Keep out of reach of children
  2. Store away from direct sunlight

KEEP OUT OF REACH OF CHILDREN

For external use only

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.

label

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)

Revised: 6/2020
Document Id: a79fb861-8578-eda8-e053-2995a90abee8
Set id: a7a03fe3-c1a5-5fae-e053-2a95a90ad69d
Version: 1
Effective Time: 20200609
 
Kwang Duk Sin Yak Co., Ltd.