Label: MINOXIDIL EXTRA STRENGTH FOR MEN- minoxidil solution

  • NDC Code(s): 68016-382-00
  • Packager: Chain Drug Consortium, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 2, 2019

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

  • Drug Facts
  • Active ingredient

    Minoxidil, USP 5% w/v

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  • Purpose

    Hair regrowth treatment for men

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  • Use

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

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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. Minoxidil topical solution 5% 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 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 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 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
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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 minoxidil topical solution 5% for men
    • In clinical studies with mostly white men aged 18 to 49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%
    • store at controlled room temperature 20° to 25°C (68° to 77°F)
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  • Inactive ingredients

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

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  • Questions?

    1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

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  • Principal Display Panel

    Premier Value®

    COMPARE TO THE ACTIVE INGREDIENT IN MEN'S ROGAINE® EXTRA STRENGTH*

    Extra Strength For Men
    Minoxidil
    TOPICAL SOLUTION, USP 5%
    HAIR REGROWTH TREATMENT

    Reactivates Hair Follicles
    to Stimulate Regrowth

    Clinically Proven to
    Help Regrow Hair

    Unscented

    NOT FOR USE BY WOMEN

    FOR BEST RESULTS
    APPLY DIRECTLY TO SCALP
    TWICE DAILY

    Two Month Supply
    Two 60mL (2 fl oz) Bottles

    INDEPENDENTLY TESTED SATISFACTION GUARANTEED

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  • INGREDIENTS AND APPEARANCE
    MINOXIDIL  EXTRA STRENGTH FOR MEN
    minoxidil solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-382
    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:68016-382-00 2 in 1 CARTON 09/11/2003
    1 60 mL in 1 BOTTLE, DROPPER; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075518 09/11/2003
    Labeler - Chain Drug Consortium, LLC (101668460)
    Registrant - Teva Pharmaceuticals USA, Inc. (001627975)
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