Label: BOSLEY MAN 5 MINOXIDIL TOPICAL SOLUTION- minoxidil solution
- NDC Code(s): 69113-431-00
- Packager: Scientific Hair Research, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 26, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Use
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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
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.
- Directions
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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.
• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men.
• in clinical studies of mostly white men age 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution
• store at controlled room temperature 20º to 25ºC (68º to 77ºF).
- Inactive ingredients
- Questions or comments?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
BOSLEY MAN 5 MINOXIDIL TOPICAL SOLUTION
minoxidil solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69113-431 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69113-431-00 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 ANDA076239 11/03/2023 Labeler - Scientific Hair Research, LLC (961897647)
