Label: NIOXIN HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil solution

  • NDC Code(s): 69282-001-18, 69282-001-60
  • Packager: The Wella Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 10, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Minoxidil 2% w/v

  • Purpose

    Hair regrowth treatment

  • Use

    to regrow hair on the scalp

  • Warnings

    For external use only

    Flammable: Keep away from fire or flame

    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 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. You may need to use this product 2 times a day 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

    • 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. (1-800-222-1222)

  • 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
  • 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.
    • in clinical studies of mostly white women aged 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 minoxidil topical solution 2% for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
    • store at 20° to 25°C (68° to 77°F). Keep tightly closed.
  • Inactive ingredients

    alcohol, propylene glycol, purified water

  • Questions?

    Call 1-800-719-9260

  • SPL UNCLASSIFIED SECTION

    MADE IN CANADA

    Dist. by THE WELLA CORPORATION,
    WOODLAND HILLS, CA 91367

  • PRINCIPAL DISPLAY PANEL - 3 Bottle Carton

    NIOXIN®

    MINOXIDIL
    TOPICAL SOLUTION USP 2%

    HAIR REGROWTH TREATMENT

    FOR WOMEN

    Clinically Proven To Help Regrow Hair
    Reactivates Hair Follicles To Stimulate Regrowth

    THREE MONTH SUPPLY
    FDA APPROVED

    3-60 mL (2 fl oz) Bottles
    UNSCENTED

    PRINCIPAL DISPLAY PANEL - 3 Bottle Carton

  • INGREDIENTS AND APPEARANCE
    NIOXIN HAIR REGROWTH TREATMENT FOR WOMEN 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69282-001
    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
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69282-001-601 in 1 CARTON11/01/2014
    160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:69282-001-183 in 1 CARTON11/01/2014
    260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535711/01/2014
    Labeler - The Wella Corporation (001399815)