BOSLEY WOMAN 2 MINOXIDIL TOPICAL SOLUTION- minoxidil solution

BOSLEY Woman 2 Minoxidil Topical Solution by

Drug Labeling and Warnings

BOSLEY Woman 2 Minoxidil Topical Solution by is a Otc medication manufactured, distributed, or labeled by Scientific Hair Research, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Minoxidil 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 more than that shown on the side of this carton. Minoxidil topical solution 2% may not work.  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 on 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 all women.

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 daydirectly 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 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 minomal regrowth).  store at controlled room temperature 20º to 25ºC (68º to 77ºF).

Inactive ingredients

Alcohol, Propylene Glycol, Purified Water

Questions or comments?

Call toll-free 1-800-BOSLEY1

• Visit Website at www.bosleymd.com

Package Labeling:

INGREDIENTS AND APPEARANCE

BOSLEY WOMAN 2 MINOXIDIL TOPICAL SOLUTION 
minoxidil solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69113-432
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69113-432-00	1 in 1 BOX	11/03/2023
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	11/03/2023

Labeler - Scientific Hair Research, LLC (961897647)