Label: HAIR REGROW- 5% minoxidil topical solution solution

  • NDC Code(s): 54111-205-60
  • Packager: Bentley Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 11, 2018

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

  • Drug Facts

  • Active ingredient

    Minoxidil 5% w/v

  • Purpose

    Hair regrowth treatment for men

  • 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 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, inflammed, infected, irritated, or painful
    • you use other medicines on the scalp
  • ASK DOCTOR

    ​Ask a doctor before use if you have heart disease

  • When using this product

    • do not apply on other part of the body
    • avoid contact with the eyes.  In case of accidental contact, rinse eyes with large amounts of cool tap water.
    • some individuals (people) have experienced changes in hair color and/or texture
    • it takes time to regrow hair.  Results may occur at 2 months with 2 times daily usage of this product.  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
    • you get unwanted facial hair growth
    • 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.

  • 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.
    • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solutions for men.
    • In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth that 2% minoxidil topical solution.
    • store at controlled room temperature 20° to 25° C (68° to 77° F)
  • Inactive ingredients

    Alcohol, Propylene Glycol, Purified Water

  • Questions?

    • 1-866-270-HAIR (4247)

    9 am to 2 pm weekdays EST

    • Visit www.MyHairRegrow.com
  • Men's Extra Strength HAIR Regrow

    Help regrow your hair with confidence

    5% Minoxidil Topical Solution

    Hair Regrowth Treatment

    Unscented

    Extra Strength Formula

    Reactivates hair follicles to stimulate regrowth

    Minoxidil is clinically proven to help regrow hair

    Compare to Men's Rogaine​® Active Ingredient*

    Not for use by women

    30 day supply / 1-60 mL (2 fl oz) bottle

    hairregrow

  • INGREDIENTS AND APPEARANCE
    HAIR REGROW 
    5% minoxidil topical solution solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-205
    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
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-205-601 in 1 CARTON08/24/2004
    160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623908/24/2004
    Labeler - Bentley Laboratories, LLC (068351753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei LLC105803274analysis(54111-205) , manufacture(54111-205)