AMINO EX 500ML- salicylic acid shampoo

AMINO EX by

Drug Labeling and Warnings

AMINO EX by is a Otc medication manufactured, distributed, or labeled by Kwang Duk Sin Yak Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

AMINO EX  500ML
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71838-0010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LEVOMENTHOL (UNII: BZ1R15MTK7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71838-0010-2	1 in 1 CARTON	06/08/2020
1	NDC: 71838-0010-1	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/08/2020

Labeler - Kwang Duk Sin Yak Co., Ltd. (688202646)

Registrant - Kwang Duk Sin Yak Co., Ltd. (688202646)

Establishment
Name	Address	ID/FEI	Business Operations
Kwang Duk Sin Yak Co., Ltd.		688202646	manufacture(71838-0010)