Label: CLUB ROOTS - TOPICAL SOLUTION HAIR REGROWTH TREATMENT- minoxidil 5% solution

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

Drug Label Information

Updated September 11, 2019

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

  • ACTIVE INGREDIENT

    Minoxidil 5% w/v

  • PURPOSE

    Hair regrowth treatment for men

  • USE

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

  • WARNINGS

    For external use only. For use by men only.

    Flammable: Keep away from fire or flame

  • DO NOT USE

    Do not use if:

    • You are a woman
    • Your amount of hair loss is different than shown on the side of this carton or hair loss is on the front of the scalp, 5% minoxidil topical solution 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 your 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 the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water
    • Some people have expereinced changes in hair color and/or texture
    • It takes time to regrow hair. Results may occur at 2 months with twice a day 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 all men
  • STOP USE

    Stop use and ask a doctor if

    • Chest pain, rapid heart beat, faintness, or dissiness occurs
    • Sudden, unexplained weight gain occurs
    • Your hands of feet swell
    • Scalp irritation or redness occurs
    • You get unwanted facial hair growth
    • You do not see hair regrowth in 4 months
  • DIRECTIONS

    • apply 1mL with sprayer (6 sprays) 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 SAFETY INFORMATION

    • See hair loss pictures on the 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 trialse with continuous treatment with 5% minoxidil topical solution for men
    • In clincial studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provide more hair regrowth than 2% minoxidil topical solution
    • Store at controlled room temperature 20 o to 25 oC (68 o to 77 o F)
  • INACTIVE INGREDIENT

    Alcohol, Propylene Glycol, Purified Water

  • 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.

  • PREGNANCY OR BREAST FEEDING

    May be harmful if used when pregnant or breast-feeding.

  • PRINCIPAL DISPLAY PANEL

    Box

  • INGREDIENTS AND APPEARANCE
    CLUB ROOTS - TOPICAL SOLUTION HAIR REGROWTH TREATMENT 
    minoxidil 5% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73359-001
    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:73359-001-011 in 1 BOX09/11/2019
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623909/11/2019
    Labeler - Roots Hair Club, LLC (117159782)