MINOXIDIL TOPICAL SOLUTION 2% solution

Minoxidil Topical Solution 2% by

Drug Labeling and Warnings

Minoxidil Topical Solution 2% by is a Otc medication manufactured, distributed, or labeled by SUN PHARMACEUTICAL INDUSTRIES, INC., Taro Pharmaceutical Industries Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Minoxidil USP 2% w/v

Purpose

Hair regrowth treatment

Use

to regrow hair on the scalp

Warnings

For external use only.

Flammable: Keep away from fire or 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 breast-feeding.

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 to 45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution 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 controlled room temperature 20º to 25º C (68º to 77º F)

Inactive ingredients

alcohol (59.85% v/v), propylene glycol, purified water

Questions?

Call toll-free 1-866-923-4914

Package/Label Principal Display Panel

NDC: 51672-2152-4

Women’s Minoxidil Topical Solution USP, 2%

HAIR REGROWTH TREATMENT

REACTIVATES HAIR FOLLICLES TO STIMULATE REGROWTH

CLINICALLY PROVEN TO HELP REGROW HAIR

UNSCENTED

One Month Supply

One 60 mL (2 fl oz) Bottle

INGREDIENTS AND APPEARANCE

MINOXIDIL TOPICAL SOLUTION 2% 
minoxidil topical solution 2% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-2152
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)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-2152-4	1 in 1 CARTON	09/01/2025
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 51672-2152-9	3 in 1 CARTON	09/01/2025
2		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	ANDA218175	09/01/2025

Labeler - SUN PHARMACEUTICAL INDUSTRIES, INC. (146974886)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceutical Industries Ltd.		600072078	manufacture(51672-2152)