Label: CAPILLUS HAIR REGROWTH TREATMENT- minoxidil liquid

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

Drug Label Information

Updated February 1, 2017

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

  • Drug Facts
  • Active Ingredient

    Minoxidil 5%

    Purpose

    Hair regrowth treatment for men

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  • Use

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

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  • Warnings

    For external use only. For use by men only.

    Flammable: Keep away from fire of flame.

    Do not use if

    • you are a women 
    • your amount of hair loss is different than that shown on the side of this carton on 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;
    • you 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 amount of cool tap water:
    • soem 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 of 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;
    • store at USP Controlled Room Temperature 20° to 25°C(68° to 77°F)
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  • Inacitve Ingredients

    alcohol, propylene glycol, purified water

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  • Questions?

    Call 1(888)272-9599 or visit www.capillus.com

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  • Package Labeling:
  • INGREDIENTS AND APPEARANCE
    CAPILLUS HAIR REGROWTH TREATMENT 
    minoxidil liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71176-781
    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:71176-781-02 1 in 1 BOX 01/24/2017
    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 01/24/2017
    Labeler - Capillus, Llc (079813345)
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