BOSLEY Man 5 Minoxidil Topical Solution

BOSLEY Man 5 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 20231026.

Generic: MINOXIDIL

Manufacturer: Scientific Hair Research, LLC

Product Type: HUMAN OTC DRUG

Route: TOPICAL

Dosage Form:

NDC: 69113-431

Application: ANDA076239

Effective: 20231026

Active Ingredients: Active Ingredient Minoxidil 5% w/v Purpose Hair regrowth treatment for men

Indications & Usage

Use to regrow hair on the top of the scalp (vertex only, see picture on side of carton)

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, For use by men only. Flammable: Keep away from fire or flame Do not use if: you are a woman your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp, 5% minoxidil topical solution is not intended for frontal baldness or receding hairline you have no family history of hair loss your hair loss is sudden and/or patchy 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, 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. Results may occur at 2 months with twice a day usage. For some men, 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 men. 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 raech of children. If swallowed, get medical help, or contact a Poison Control Center right away.

Adverse Reactions

Not available.

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