MINOXIDIL TOPICAL SOLUTION USP, 2%- minoxidil 2% solution

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Minoxidil 2% w/v

Purpose

Hair growth treatment

Use

to regrow hair on the scalp

Warnings

For external use only

Flammable: Keep away from flame

Do not use if

your degree of hair loss is different than that shown on the
side of this carton, because this product may not work for you

you have no
family history of hair loss

your hair loss is sudden and/or patchy your hair
loss is associated with childbirth

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

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. You may need to use this
product 2 times a day 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 everyone

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 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 breastfeeding. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right
away. (1-800-222-1222)

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 continued use is
necessary to increase and keep 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. in clinical studies of mostly white women aged 18–45 years with
mild to moderate degrees of hair loss, the following response to minoxidil topical
solution 2% was reported: 19% of women reported moderate regrowth after
using minoxidil topical solution 2% for 8 months (19% had moderate regrowth;
40% had minimal regrowth) this compares with 7% of women reporting
moderate hair regrowth after using the placebo, the liquid without minoxidil in it,
for 8 months (7% had moderate regrowth; 33% had minimal regrowth) store
at 20° to 25°C (68° to 77°F). Keep tightly closed.

Inactive ingredients

alcohol, propylene glycol, purified water

Questions or comments

1-877-540-2101

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINOXIDIL TOPICAL SOLUTION USP, 2% 
minoxidil 2% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87532-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87532-001-01	1 in 1 BOX	04/03/2026
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
ANDA	ANDA078176	04/03/2026

Labeler - Carol's Daughter, LLC (137231376)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source		080354456	manufacture(87532-001)