The Fact-HFN Cooling Anti-hair Loss TonicGel by Gragem Inc. Drug Facts

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 Gragem Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

panthenol

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

Helps relieve and revitalizing scalp.

keep out of reach of the children

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.

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.

for external use only

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82468-0001
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: 82468-0001-1	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/24/2021	01/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/15/2021	01/15/2022

Labeler - Gragem Inc. (693705281)

Registrant - Gragem Inc. (693705281)

Establishment
Name	Address	ID/FEI	Business Operations
Gragem Inc.		693705281	manufacture(82468-0001) , label(82468-0001)

Revised: 1/2022

Document Id: d61093b1-d1f4-7be2-e053-2995a90a7412

34390-5

Set id: d3dcc800-2896-9544-e053-2a95a90ae65c

Version: 3

Effective Time: 20220120