Label: ROOTLY EXTRA STRENGTH HAIR REGROWTH TREATMENT FOR MEN- minoxidil 5% solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 18, 2023

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

  • ACTIVE INGREDIENT

    Minoxidil 5% w/v

  • PURPOSE

    Hair regrowth treatment for men

  • USE

    to regrow hair on the top of the scalp

  • WARNINGS

    For external use only.

    Flammable: Keep away from fire or flame.

  • DO NOT USE

    Do not use if

    • You are a woman
    • Your degree of hair loss is different than that shown on 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 or children.
    • Your scalp is red, inflammed, infected, irritated, or painful
    • You use other medicines on your scalp
  • ASK DOCTOR

    Ask a doctor before use if you have heart disease

  • WHEN USING

    When using this product

    • Do not apply on other parts of the body
    • Avoid contact with eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
    • Some people have experienced change in hair color and/or texture. It takes time to regrow hair. For some men, 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 all men.
  • STOP USE

    Stop use and ask 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
  • 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 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 leaflet

    • 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 5% minoxidil topical solution for men

    • in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution

    • store at controlled room temperature 68º to 77ºF (20º to 25ºC).

  • INACTIVE INGREDIENT

    lcohol, Propylene Glycol, Purified Water

  • QUESTIONS

    Questions or comments

    Call toll-free 1-800-681-0241 or visit hellorootly.com

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    ROOTLY EXTRA STRENGTH HAIR REGROWTH TREATMENT FOR MEN 
    minoxidil 5% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70150-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70150-005-011 in 1 BOX08/24/2021
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623908/24/2021
    Labeler - TTEM, LLC (079997910)