Label: THE FACT HAIR CARE SCALP BOOSTER AMPOULE- l-menthol, salicylic acid, dexpanthenol liquid
- NDC Code(s): 77049-0013-1
- Packager: Interkos Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated February 11, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
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 - PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THE FACT HAIR CARE SCALP BOOSTER AMPOULE
l-menthol, salicylic acid, dexpanthenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77049-0013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL 0.2 g in 100 mL LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 0.3 g in 100 mL SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.25 g in 100 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77049-0013-1 20 mL in 1 TUBE; Type 0: Not a Combination Product 02/11/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/11/2023 Labeler - Interkos Co.,Ltd. (689850314) Registrant - Interkos Co.,Ltd. (689850314) Establishment Name Address ID/FEI Business Operations Interkos Co.,Ltd. 689850314 manufacture(77049-0013)
