FOLLICLE FOLLIXIL 5% MINOXIDIL HAIR REGROWTH-LOTION- follicle follixil 5% minoxidil hair regrowth-lotion liquid 
Guangzhou Ariel Biotech Co., Ltd.

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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Active Ingredient(s)

Minoxidil 5%

Purpose

Hair regrowth treatment for men.

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton.

Warnings

For external use only. For use by men only.

Flammable: Keep away from fire or flame

Do not use

●You are a woman.
●Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the
scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
●You have no family history 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 on babies and children.
●Your scalp is red, inflamed, infected, iritated or painful.
●You use other medicines on the scalp.

●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 all men.

●Chest pain, rapid heartbeat, faintness or dizziness occurs.
●Sudden, unexplained weight gain occurs.
●Your hands or feet swell.
●Scalp iritation or redness occurs.
●Unwanted facial hair growth occurs.
●You do not see hair regrowth in 4 months.

May be harmful if used when pregnant or breast-feeding. Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

●Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area.
●Using more or more often will not improve results.
●Continuous use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

Other information

1.See hair loss pictures on side of this carton.
2.Before use, read all information on carton and enclosed leaflet.
3.Keep the carton. It contains important information.
4.Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil
topical solution 5% for men.
5.In clinical studies with mostly white men aged between 18-49 years with moderate degrees of hair loss, monoxidil topical
solution 5% for men provided more hair regrowth than minoxidil topical solution 2%,
6.Store at 20° to 259C (68° to 77°F). Keep tightly closed.

Inactive ingredients

Water, Alcohol, Propylene Glycol, Glycerol, Biotin, Caffeine, Niacinamide

Package Label - Principal Display Panel

label

FOLLICLE FOLLIXIL 5% MINOXIDIL HAIR REGROWTH-LOTION 
follicle follixil 5% minoxidil hair regrowth-lotion liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84148-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
BIOTIN (UNII: 6SO6U10H04)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CAFFEINE (UNII: 3G6A5W338E)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84148-005-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/17/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/17/2024
Labeler - Guangzhou Ariel Biotech Co., Ltd. (402818771)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Ariel Biotech Co., Ltd.402818771manufacture(84148-005)

Revised: 4/2024
Document Id: 16454376-ea17-33d0-e063-6294a90a0a62
Set id: 16454f24-8333-4b6f-e063-6294a90a1c49
Version: 1
Effective Time: 20240417
 
Guangzhou Ariel Biotech Co., Ltd.