Otc - Active Ingredient
menthol
salicylic acid
panthenol
The Fact-hfn Cooling Anti-hair Loss Tonicgel
FDA Label NDC 77049-0011
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-hfn Cooling Anti-hair Loss Tonicgel (NDC 77049-0011). 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
Glycerin
PEG-60 Hydrogenated Castor Oil
Tromethamine
Carbomer
Trideceth-10
Fragrance
Butylene Glycol
1,2-Hexanediol
Caprylyl Glycol
Brassica Oleracea Italica (Broccoli) Extract
Illicium Verum (Anise) Fruit Extract
Sodium Hyaluronate
Geraniol
Linalool
Citronellol
Hexyl Cinnamal
Limonene
Otc - Purpose
Helps relieve and revitalizing scalp.
Otc - Keep Out Of Reach Of Children
keep out of reach of the children
Indications & Usage
After shampooing and before drying, apply an appropriate am
ount to the scalp in a wet state using your fingers and massage
so that it is fully absorbed. It ries commended to use it at least 3
times a week.
Warnings
1. If you have any of the following side effetsc while using, you
should stop using, iatnd if you continue to use, iytour sympt
oms will worsen, so consult your dermatologist.
-If there are side effects such as red spots, swelling, itching, irrita
tion during use.
-If the application area has the above side efftesc
due to direct sunlight
2. Do not use on areas with wounds, eczema or dermatitis.
3. Precautions for stoarge and handling
- Be sure to close the cap taefr use.
- Do not store where children may reach.
- Store in a place with high or low tempaeturre and out of dire
ct sunlight.
4. In case of contact with eyes, rinse immediately and consult
a physician.
5. People who have ever had allergies, please consult your dotc
or or pharmacist before use
6. Do not use on children under 3 years ogfe a.
7. People with hypersensitivity to salicylic acid or who hasa bdei
tes, blood circulation disorders, renala filure, infection, redness,
those who are pregnant or may become pregnant should av
oid using the pdrouct as the current symptoms may worsen
a fter use, such as skin or body hypersensitivity or skin adverse
reatcions (edema, inflammation, etc.). So please avoid using it.
- Product Liability Act (PL Act): Before use, be sure to read the
instructions for use and precautions.
Dosage & Administration
for external use only
Package Label.Principal Display Panel
Label (Label)
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