FOLLIXIL HAIR REGROWTH TREATMENT- 2% minoxidil liquid

FOLLIXIL Hair Regrowth Treatment by

Drug Labeling and Warnings

FOLLIXIL Hair Regrowth Treatment by is a Otc medication manufactured, distributed, or labeled by Matykos Beauty LLC, Guangzhou Colif Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

FOLLIXIL HAIR REGROWTH TREATMENT 
2% minoxidil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83835-231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83835-231-21	1 in 1 BOX	02/27/2024
1	NDC: 83835-231-02	60 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 83835-231-23	3 in 1 BOX	02/27/2024
2	NDC: 83835-231-02	60 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/27/2024

Labeler - Matykos Beauty LLC (118726242)

Registrant - Matykos Beauty LLC (118726242)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Colif Cosmetics Co., Ltd		699427130	manufacture(83835-231)