Label: 5% MINOXIDIL TOPICAL SOLUTION- minoxidil solution

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

Drug Label Information

Updated April 1, 2019

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

  • ACTIVE INGREDIENT

    Minoxidil 5% w/v

  • PURPOSE

    Hair regrowth treatment

  • INDICATIONS & USAGE

    Use to regrow hair on the scalp

  • WARNINGS

    For external use only, For use by men only.

    Flammable: Keep away from fire or flame

  • DO NOT USE

    • you are a woman
    • your amount of hair loss is different than that shown on the side of this carton or your 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 and children
    • your scalp is red, inflamed, irritated or painful • you use other medicines on the scalp
  • ASK DOCTOR

    Ask a doctor before use if you have heart disease

  • WHEN USING

    • 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. 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 heartbeat, faintness, or dizziness occurs

    • sudden, unexplained weight gain occurs

    • your hands or feet swell

    • scalp irritation of 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INSTRUCTIONS FOR USE

    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 SAFETY INFORMATION

    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 age 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 USP controlled room temperature 20º to 25ºC (68º to 77ºF).

  • INACTIVE INGREDIENT

    Inactive Ingredients: Alcohol, Propylene Glycol, Purified Water

  • DOSAGE & ADMINISTRATION

    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

  • PRINCIPAL DISPLAY PANEL

    Avacor product label

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL TOPICAL SOLUTION 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49539-001
    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
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49539-001-013 in 1 CARTON04/01/2019
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623904/01/2019
    Labeler - AVACOR PRODUCTS, LLC (080364950)
    Registrant - AVACOR PRODUCTS, LLC (080364950)