Label: BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT REGULAR STRENGTH FOR MEN- minoxidil liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 10, 2017

If you are a consumer or patient please visit this version.

  • BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Men
  • Active Ingredient

    Minoxidil 5.0% w/v

    Purpose

    Hair regrowth treatment for men

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  • Use

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

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  • Warnings

    For external use 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 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, infected, irritated, or painful
    • you use other medications 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. Result may occur all 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 feel 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.

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  • Directions

    • apply one ML 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 or hair loss will begin again
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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 growth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Minoxidil Topical Solution 5%
    • in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% provided more hair regrowth than Minoxidil Topical Solutions 2%
    • store at controlled room temperature 20 degree to 25 degree C (68 degree to 77 degree F)
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  • Inactive ingredients

    alcohol 30% v/v, propylene glycol 50% v/v, purified water

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  • Questions or comments?

    questions: call your health professional or Bosley at 1(800)BOSLEY1

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  • BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Men 2-60ml (65121-102-05)
  • INGREDIENTS AND APPEARANCE
    BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT REGULAR STRENGTH FOR MEN 
    minoxidil liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:65121-102
    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:65121-102-05 2 in 1 CARTON 02/09/2017
    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 08/15/2013
    Labeler - Pure Source, LLC (080354456)
    Establishment
    Name Address ID/FEI Business Operations
    Pure Source, LLC 080354456 manufacture(65121-102)
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