THE FACT-HFN COOLING ANTI-HAIR LOSS TONICGEL- menthol, salicylic acid, panthenol gel

The Fact-HFN Cooling Anti-hair Loss TonicGel by

Drug Labeling and Warnings

The Fact-HFN Cooling Anti-hair Loss TonicGel by is a Otc medication manufactured, distributed, or labeled by Interkos Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

menthol

salicylic acid

panthenol

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

PURPOSE

Helps relieve and revitalizing scalp.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THE FACT-HFN COOLING ANTI-HAIR LOSS TONICGEL 
menthol, salicylic acid, panthenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77049-0011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.3 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.04 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
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77049-0011-1	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/21/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/21/2022

Labeler - Interkos Co.,Ltd. (689850314)

Registrant - Interkos Co.,Ltd. (689850314)

Establishment
Name	Address	ID/FEI	Business Operations
Interkos Co.,Ltd.		689850314	manufacture(77049-0011)