FOLIGAIN PROFESSIONAL SERIES EXTRA STRENGTH FOR WOMEN MINOXIDIL TOPICAL HAIR REGROWTH TREATMENT- minoxidil solution

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment for women

Use

to regrow hair on the scalp. (see picture on side of carton)

Warnings

For external use only. For use by women only. Flammable:Keep away from fire or flame.

Do not use if you:

have hair loss associated with childbirth.
have hair loss other than that shown on the side of this carton, because this product may not work for you.
have no family history of hair loss.
have sudden and/or patchy hair loss.
do not know the reason for your hair loss.
are under 18 years of age.
have a red, inflamed, infected, irritated or painful-feeling scalp.
use other medicines on the scalp.

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 women, 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 women.

Stop use and ask a doctor if you experience:

chest pain, rapid heartbeat, faintness, or dizziness.
sudden, unexplained weight gain.
swelling of the hands or feet.
scalp irritation or redness.
unwanted facial hair growth.
no hair regrowth in 4 months.

May be harmful if used when pregnant or breastfeeding.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply 1 mL with dropper two (2) times a day directly onto the scalp in the hair loss area.
Using more product, or using product more often will not improve results.
Continued use is necessary to increase and maintain your hair regrowth, or hair loss will begin again.

Other information

See hair loss pictures on side of this carton.
Before use, read all information on carton and enclosed leaflet.
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 2% minoxidil topical solution for women.
In clinical studies of mostly white women aged 18-49 years with moderate degrees of hair loss, 2% minoxidil topical solution for women provided more hair regrowth than 2% minoxidil topical solution.
Store at controlled room temperature 20º to 25ºC (68º to 77ºF).

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water.

Questions or comments?

call us at +1 (844) 473-7279
visit www.foligain.com

Package Labeling:

INGREDIENTS AND APPEARANCE

FOLIGAIN PROFESSIONAL SERIES EXTRA STRENGTH FOR WOMEN MINOXIDIL TOPICAL HAIR REGROWTH TREATMENT 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69607-9530
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69607-9530-0	3 in 1 BOX	05/05/2026
1		60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078176	05/05/2026

Labeler - WR Group, Inc. (089173699)

Registrant - Pure Source, LLC (080354456)