Label: KEEPS- minoxidil 5% liquid

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

Drug Label Information

Updated December 30, 2017

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

  • ACTIVE INGREDIENT

    Minoxidil 5.0% w/v

  • PURPOSE

    Hair regrowth treatment for men

  • INDICATIONS & USAGE

    to regrow hair on the scalp (vertex only, see picture on side of carton)

  • WARNINGS

    For external use only. For use by men only.
    Flammable: Keep away from fire or flame
    Do not use if:
    • 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 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. 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 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

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

  • DOSAGE & ADMINISTRATION

    • 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

    • 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 20º to 25ºC (68º to 77ºF).

  • INACTIVE INGREDIENT

    Alcohol, Propylene Glycol, Purified Water

  • QUESTIONS

    Questions or comments?
    1-833-745-3377

  • PRINCIPAL DISPLAY PANEL

    box art

  • INGREDIENTS AND APPEARANCE
    KEEPS 
    minoxidil 5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71713-095
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71713-095-103 in 1 BOX11/15/2017
    160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07458811/15/2017
    Labeler - Thirty Madison Inc (080774087)