Label: CAPILLUS HAIR REGROWTH TREATMENT- minoxidil liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 1, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active Ingredient

    Minoxidil 5%

    Purpose

    Hair regrowth treatment for men

  • Use

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

  • 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.

  • 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.
  • 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)
  • Inacitve Ingredients

    alcohol, propylene glycol, purified water

  • Questions?

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

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CAPILLUS HAIR REGROWTH TREATMENT 
    minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71176-781
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71176-781-021 in 1 BOX01/24/2017
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623901/24/2017
    Labeler - Capillus, Llc (079813345)