Label: FOLLINIQUE- minoxidil solution

  • NDC Code(s): 70788-579-01
  • Packager: Premium Distribution, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 27, 2017

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

  • Active ingredients:

    Minoxidil 2.0% w/v

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  • Purpose

    Hair regrowth treatment

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  • Use

    to regrow hair on the scalp

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  • Warnings

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

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  • Do not use if

    • your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you
    • you have no family history of hair loss
    • your hair loss is sudden and/or patchy
    • your hair loss is associated with childbirth
    • 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
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  • ASK DOCTOR

    Ask a doctor before use if you have heart disease.

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  • 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 waler.
    • some people have experienced changes in hair color and/or texture
    • it takes time to regrow hair. You may need to use this product 2 times a day 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
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  • 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
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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    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
    • in clinical research in mostly white women age 18-45 years with mild to moderate degrees of hair loss, the following response to Minoxidil Topical Solution 2% was reported: 19% of women reported moderate hair regrowth after using women's Minoxidil Topical Solution 2% for 8 months; 19% had moderate regrowth; 40% had minimal regrowth. This compares with 7% of women reporting hair regrowth after using the placebo, the liquid without Minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal regrowth)
    • keep the carton. It contains important information.
    • store at controlled room temperature 200 to 250C (680 to 770F).
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  • Inactive Ingredients:

    alcohol , propylene glycol, purified water.

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  • Questions or comments?

    877-279-9024

    Visit website at www.follinique.com

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  • PRINCIPAL DISPLAY PANEL

    NDC 70788-579-01

    Follinique

    Women's 2% Minoxidil Topical Solution USP

    Hair Regrowth Treatment

    Reactivates Hair Follicles to Stimulate Regrowth

    Clinically Proven to Help Regrow Hair

    Unscented Topical Solution

    follinique

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  • INGREDIENTS AND APPEARANCE
    FOLLINIQUE 
    minoxidil solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70788-579
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70788-579-01 1 in 1 CARTON 10/27/2016
    1 60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078176 10/27/2016
    Labeler - Premium Distribution, LLC (079805390)
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