Label: LOESCH HAIR REGROWTH FORMULA UNSCENTED TOPICAL SOLUTION REGULAR-STRENGTH FOR MEN AND WOMEN- minoxidil solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 22, 2019

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

  • Drug Facts

  • Active Ingredients

    Minoxidil 2% w/v

  • Purpose

    Hair Regrowth Treatment

  • Use

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

  • Warnings

    For external use only. Flammable: Keep away from fire or flame.

  • Do not use if

    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 2% 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 or children.
    Your scalp is red, inflamed, infected, irritated, or painful.
    You use other medicines on the scalp.

  • ASK DOCTOR

    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. Results may occur at 2 months with twice daily 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 everyone.

  • Stop use and ask a doctor if you have

    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.

  • Pregnancy or breast feeding

    ​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 immediately. (1-800-222-1222)

  • Directions

    Apply one mL 2 times daily 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 resume.

  • Other information

    See hair loss picture on the side of this carton.
    Before use, read all information on carton and printed insert.
    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 2%.
    In clinical studies with mostly caucasian women aged 18-45 years with mild to no moderate degrees of hair loss, the following respone to Minoxidil Topical Solution 2% was reported: 19% of women reported moderate hair regrowth after using Minoxidil Topical Solution 2% for 8 months. This compares with 7% of women reporting moderate hair regrowth and 33% reporting minimal regrowth after using the placebo, the liquid without minoxidil in it, for 8 months.

  • Inactive Ingredients

    Alcohol, Propylene Glycol, Purified water

  • Questions or Comments?

    1-800-237-7157

  • PRINCIPAL DISPLAY PANEL

    2% Minoxidil2% Minoxidil box

  • INGREDIENTS AND APPEARANCE
    LOESCH HAIR REGROWTH FORMULA  UNSCENTED TOPICAL SOLUTION REGULAR-STRENGTH FOR MEN AND WOMEN
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25280-007(NDC:49035-202)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:25280-007-421 in 1 PACKAGE08/11/2014
    160 mL in 1 BOTTLE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535708/11/2014
    Labeler - Loesch Laboratory Consultant, INC. (026619510)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation072186356relabel(25280-007)