AMINO EX HAIR TONIC 500ML- salicylic acid liquid

AMINO EX HAIR TONIC by

Drug Labeling and Warnings

AMINO EX HAIR TONIC 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, Alcohol, Biotite, Glycerin, Polysorbate 80, PEG-60 Hydrogenated Castor Oil, Citric Acid, Sodium Benzoate, L-Menthol, Salicylic Acid, Dimethyl Sulfone, Arginine, Dexpanthenol, Sulfur, Disodium EDTA

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

• Do not use on children under 3 years of age.
• Rinse your eyes with water if they are exposed to the product.
• Those who have had allergic symptoms should consult a doctor and pharmacist before use.
• Those who are hypersensitive to salicylic acid or have diabetes, blood circulation disorders, kidney failure, infection, redness, etc., and who are on their period, are pregnant or may be pregnant should not use it because the current symptoms are likely to worsen after use, such as hypersensitive skin or body or an abnormal skin reaction (edema, inflammation, etc.).

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

For external use only

DOSAGE & ADMINISTRATION

Shake the product thoroughly before use, apply an appropriate amount evenly on the scalp, and rub it with your fingers to absorb it as if massaging.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMINO EX HAIR TONIC  500ML
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71838-0011
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: 71838-0011-2	1 in 1 CARTON	06/08/2020
1	NDC: 71838-0011-1	110 mL in 1 BOTTLE, SPRAY; 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(71838-0011)