ETERNAL SPIRIT BEAUTY - 5% Minoxidil Topical Solution

5% Minoxidil Topical Solution by

Drug Labeling and Warnings

5% Minoxidil Topical Solution by is a Otc medication manufactured, distributed, or labeled by FLPHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

5% MINOXIDIL TOPICAL SOLUTION 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71724-400
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
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71724-400-60	1 in 1 CARTON	01/19/2022
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/19/2022	02/10/2022

Labeler - FLPHARMACEUTICALS LLC (080682491)

Registrant - FLPHARMACEUTICALS LLC (080682491)

Revised: 11/2022

Document Id: ed883953-9a4a-5349-e053-2a95a90ae018

34390-5

Set id: eb6f13da-7efd-4799-91a9-1a3c66ad98af

Version: 4

Effective Time: 20221115