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

  • 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 January 20, 2022

If you are a consumer or patient please visit this version.

  • 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

    label

  • INGREDIENTS AND APPEARANCE
    THE FACT-HFN COOLING ANTI-HAIR LOSS TONICGEL 
    menthol, salicylic acid, panthenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77049-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.3 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.04 g  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77049-0011-1150 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/21/2022
    Labeler - Interkos Co.,Ltd. (689850314)
    Registrant - Interkos Co.,Ltd. (689850314)
    Establishment
    NameAddressID/FEIBusiness Operations
    Interkos Co.,Ltd.689850314manufacture(77049-0011)