Label: FOLLIXIL HAIR REGROWTH TREATMENT- 2% minoxidil liquid

  • NDC Code(s): 83835-231-02, 83835-231-21, 83835-231-23
  • Packager: Matykos Beauty LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 27, 2024

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  • Active ingredient

    Minoxidil 2% w/v

  • Purpose

    Hair regrowth treatment

  • Use

    to regrowth hair.

  • Warnings

    For external use only. For use by men only.

    Flammable. Keep away from fire or flame.

  • Indications

    • Prevent and Stop Hair Loss.
    • Stimulate Hair Growth.
    • Improve Fullness of Hair.
    • Restore Vitality of Hair.
    • Strengthen and Activates Dormant Hair Follicles.
  • Do not use if

    • you have no family histoy of hair loss.
    • your hair loss is sudden and/or patchy.
    • you do not know the reason for your hair loss.
    • you are under 18 years of age. Do not use if on babies and children.
    • your scalp is red, inflamed, infected, irritated, or painful.
    • you use other medicines on the scalp.
  • ASK DOCTOR

    Ask a doctor before use if you have heart disease.

  • When using this product

    • do not apply on other parts of the body.
    • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
    • some people have experienced changes in hair color and/or texture.
    • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.
    • the amount of hair regrowth is different for each person. This product will not work for everyone.
  • Stop use and ask doctor if

    • chest pain, rapid heartbeat, faintness, or dizziness occurs
    • sudden, unexplained weight gain occurs
    • your hands or feet swell
    • scalp irritation or redness occurs
  • KEEP OUT OF REACH OF CHILDREN

    Do not use it on babies and children.

  • Inactive Ingredients

    alcohol, butylene glycol, water, vitamin h, rosmarinus officinalis (rosemary) leaf water, ethoxydiglycol, 1.2-hexanediol, polyglycerin-10, sodium, polyglutamate, ethylhexylglycerin, niacinamide, caffeine, cyclodextrin.

  • Store

    at 20 to 25℃ (68 to 77℉), and keep tightly closed.

  • CAUTIONS

    Don't use Follixil if you are:

    • Pregnant.
    • Having heart sensitivity.
    • Super-sensitive skin.
    • Having open wounds.
    • Unexcited to boost your follicles and to achieve bushy hair!
    • Planning to do physical activities in the next hour.
  • DIRECTIONS

    • Apply one mL with a dropper 2 times a day directly onto the scalp in the hair loss area.
    • Using more or more often will not improve results.
    • Continued use is necessary to increase and keep your hair regrowth.
  • Other information:

    • Before use, read all the information on the carton and the inside brochures.
    • Store at 20 to 25℃ (68 to 77℉). Keep tightly closed.
  • PRINCIPAL DISPLAY PANEL

    231-02231-21231-23

  • INGREDIENTS AND APPEARANCE
    FOLLIXIL HAIR REGROWTH TREATMENT 
    2% minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83835-231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAFFEINE (UNII: 3G6A5W338E)  
    CYCLODEXTRINS (UNII: 7E6SK9QDT8)  
    BIOTIN (UNII: 6SO6U10H04)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    WATER (UNII: 059QF0KO0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYGLYCERIN-10 (UNII: P9060O936A)  
    SODIUM (UNII: 9NEZ333N27)  
    POLYGLYCOLIC ACID (UNII: H1IL6F7KB8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83835-231-211 in 1 BOX02/27/2024
    1NDC:83835-231-0260 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:83835-231-233 in 1 BOX02/27/2024
    2NDC:83835-231-0260 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/27/2024
    Labeler - Matykos Beauty LLC (118726242)
    Registrant - Matykos Beauty LLC (118726242)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Colif Cosmetics Co., Ltd699427130manufacture(83835-231)
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