BOSLEY Woman 2 Minoxidil Topical Solution

BOSLEY Woman 2 Minoxidil Topical Solution is an FDA drug label for the active ingredient MINOXIDIL manufactured by Scientific Hair Research, LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231218.

Generic: MINOXIDIL

Manufacturer: Scientific Hair Research, LLC

Product Type: HUMAN OTC DRUG

Route: TOPICAL

Dosage Form:

NDC: 69113-432

Application: ANDA078176

Effective: 20231218

Active Ingredients: Active Ingredient Minoxidil 2% w/v Purpose Hair regrowth treatment

Indications & Usage

Use to regrow hair on the scalp

Dosage & Administration

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

Contraindications

Not available.

Warnings

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.

Adverse Reactions

Not available.

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