5% MINOXIDIL TOPICAL SOLUTION- minoxidil solution 
FLPHARMACEUTICALS LLC

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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ETERNAL SPIRIT BEAUTY - 5% Minoxidil Topical Solution

Minoxidil 5% w/v

Hair regrowth treatment

To regrow hair on the scalp

For external use only.

  • Do not use if: • your amount of hair loss is on the front of the scalp, 5% minoxidil topical solution is not intentad 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• your are under 18 years of age. Do not use on babies and children • your scalp is red, inflamed, irritated or painful • you use other medicines on the scalp.

Ask a doctor before use if you have heart disease

• 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.

Stop use and ask a doctor if

• chest pain, rapid heartbeat, faintness, or dizziness occurs

• sudden, unexplained weight gain occurs

• your hands or feet swell

• scalp irritation of 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.

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

• continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Other Information

• Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution.
• In clinical studies of mostly white men age 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution provided more hair regrowth than 2% minoxidil topical solution.

• Store at USP controlled room temperature 20° to 25°C (68° to 77° F.)

Inactive Ingredients: Alcohol, Propylene Glycol, Purified Water

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

• continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

MINOXIDIL

5% MINOXIDIL TOPICAL SOLUTION 
minoxidil solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71724-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71724-400-601 in 1 CARTON01/19/2022
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/19/202202/10/2022
Labeler - FLPHARMACEUTICALS LLC (080682491)
Registrant - FLPHARMACEUTICALS LLC (080682491)

Revised: 11/2022
 
FLPHARMACEUTICALS LLC