THE FACT HAIR CARE SCALP BOOSTER AMPOULE- l-menthol, salicylic acid, dexpanthenol liquid 
Interkos 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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Drug Facts

-menthol, Salicylic acid, Dexpanthenol

Water
Alcohol
PEG-60 Hydrogenated Castor Oil
Trideceth-10
Fragrance
Butylene Glycol
1,2-Hexanediol
Caprylyl Glycol
Tromethamine
Ginkgo Biloba Leaf Extract
Sophora Flavescens Extract
Urtica Dioica (Nettle) Extract
Carthamus Tinctorius (Safflower) Flower Extract
Brassica Oleracea Italica Extract
Carbomer
Pueraria Lobata Root Extract
Illicium Verum (Anise) Fruit Extract
Sodium Hyaluronate

Helps treat hair loss symptoms

KEEP OUT OF REACH OF THE CHILDREN

Shake the product thoroughly, then apply evenly onto the scalp with the massage roller.

1) After application, if there are any abnormal symptoms or side effects such as red spots, swelling, or itching in the area from direct sunlight, please consult with a specialist.

2) Avoid using the product on areas with scarring or open wounds.

3) Storage and handling

A) Keep out of reach of children

B) Keep away from direct sunlight

4) Keep out of eyes, if this occurs, rinse immediately with water

5) For any adverse allergic reactions, please consult your doctor or pharmacist before use.

6) Not for children under the age of 3

7) Those with diabetes, blood circulation disorder, renal failure, infection, redness, hypersensitivity to salicylic acid, etc., and those who are pregnant or likely to become pregnant may experience skin or body hypersensitivity or skin adverse reactions (edema, inflammation, etc.). Avoid using the product if symptoms arise

external use only

label

THE FACT HAIR CARE SCALP BOOSTER AMPOULE 
l-menthol, salicylic acid, dexpanthenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77049-0013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL0.2 g  in 100 mL
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL0.3 g  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77049-0013-120 mL in 1 TUBE; Type 0: Not a Combination Product02/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/11/2023
Labeler - Interkos Co.,Ltd. (689850314)
Registrant - Interkos Co.,Ltd. (689850314)
Establishment
NameAddressID/FEIBusiness Operations
Interkos Co.,Ltd.689850314manufacture(77049-0013)

Revised: 2/2023
Document Id: f469f1e5-24b1-8ade-e053-2995a90a3028
Set id: f469f1d3-adc1-a719-e053-2995a90ad08a
Version: 1
Effective Time: 20230211
 
Interkos Co.,Ltd.