Label: WOMENS ROGAINE UNSCENTED- minoxidil solution

  • NDC Code(s): 69968-0090-1, 69968-0090-3
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 19, 2016

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.

  • 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 booklet
    • 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 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution 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 controlled room temperature 20° to 25° C (68° to 77° F)
  • Inactive ingredients

    alcohol, propylene glycol, purified water

  • Questions?

    • call toll-free 800-764-2463 or 215-273-8755 (collect)
    • visit www.rogaine.com
  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

    #1 DERMATOLOGIST
    RECOMMENDED BRAND

    WOMEN'S
    Rogaine®

    2% Minoxidil
    Topical Solution

    Hair Regrowth
    Treatment

    REACTIVATES
    HAIR FOLLICLES
    TO STIMULATE
    REGROWTH

    CLINICALLY PROVEN
    TO HELP REGROW HAIR

    Topical Solution

    UNSCENTED

    One Month Supply
    One 60 mL (2 fl oz) Bottle

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    WOMENS ROGAINE UNSCENTED 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1) Minoxidil20 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:69968-0090-11 in 1 CARTON08/01/2010
    160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69968-0090-33 in 1 CARTON08/01/2010
    260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01950108/01/2010
    Labeler - Johnson & Johnson Consumer Inc. (002347102)