FINALLY HAIR MINOXIDIL 5% HAIR GROWTH FOAM (hair growth foam- serum liquid

FINALLY HAIR MINOXIDIL 5% HAIR GROWTH FOAM by

Drug Labeling and Warnings

FINALLY HAIR MINOXIDIL 5% HAIR GROWTH FOAM by is a Otc medication manufactured, distributed, or labeled by Guangzhou Jianyuan Biological Technology Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Minoxidil 5% w/ v.

Purpose

Hair regrowth treatment for people

Use

to regrow hair on the top of the scalp

Warnings

For external use only. Avoid getting product in your eyes or mouth. If contact occurs, rinse with water and consultant a doctor. Keep out of reach of children. Do not apply on broken or irritated skin.

Do not use

■ you are a pregnant woman
■ 5% minoxidil topical solution 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, irritated, or painful
■ you use other medicines on the scalp

When Using

■ 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 people, 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 people.

Stop Use

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

Ask Doctor

heart disease

Keep Oot Of Reach Of Children

Yes, Keep Oot Of Reach Of Children

Directions

■ apply right amount directly to the scalp in the hair loss area.
■ massage into scalp with fingers, then wash hands well.
■ using more or more often will not improve results.
■ continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.
For best results: Keep using (Men use twice a daily. Women use once a day).

Other information

■ see hair loss pictures on side of this carton
■ before use, read all information on carton
■ keep the carton. It contains important information.
■ hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Hair Regrowth Treatment for men and women
■ In clinical studies with mostly white men and women aged 18-49 years with moderate degrees of hair loss, Hair Regrowth Treatment for people provided more hair regrowth than minoxidil topical solution 2%
■ store at 20° to 25°C (68° to 77°F). Keep tightly closed.

Inactive ingredients

Aqua， Biotin, EDTA ,Methylparaben, Allantoin, Adenosine, Niacinamide, Water Soluble Azone， Phenoxyethanol, Propylene Glycol, Collagen

Questions

Info@finallyhair.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FINALLY HAIR MINOXIDIL 5% HAIR GROWTH FOAM 
hair growth foam (serum) liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81653-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
NIACINAMIDE (UNII: 25X51I8RD4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
COLLAGEN ALPHA-1(I) CHAIN BOVINE (UNII: FB3DQM32F2)
METHYLPARABEN (UNII: A2I8C7HI9T)
TETRAMETHYLCHROMANOL GLUCOSIDE (UNII: 7YWI9T8733)
ADENOSINE (UNII: K72T3FS567)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81653-011-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075357	12/08/2023

Labeler - Guangzhou Jianyuan Biological Technology Co.,Ltd (548120189)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Jianyuan Biological Technology Co.,Ltd		548120189	manufacture(81653-011)