Otc - Active Ingredient
-menthol, Salicylic acid, Dexpanthenol
The Fact Hair Care Scalp Booster Ampoule
FDA Label NDC 77049-0013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Interkos Co.,ltd. for the product The Fact Hair Care Scalp Booster Ampoule (NDC 77049-0013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Purpose
Helps treat hair loss symptoms
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF THE CHILDREN
Indications & Usage
Shake the product thoroughly, then apply evenly onto the scalp with the massage roller.
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
external use only
Package Label.Principal Display Panel
Label (Label)
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