Label: MENS RAPID REINVENT 5 MINOXIDIL SOLUTION- minoxidil liquid

  • NDC Code(s): 83719-427-00
  • Packager: THE SELF AND BODY LOVE COMPANY LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 4, 2023

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 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 hairloss 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

    • unwated 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    apply one mL with dropper 2 times a daydirectly onto the scalp in the loss area • Using more or often will not improve results • Continued use is necessary or hair loss will begin again

  • Other Information

    • see hari 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 trails with continuous treatment with 5% minoxidil topical solution for men • in clinical studies of mostly white men aged 18-49 years with moderate degree of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 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 or comments?

    1(888) 888-9348 Visit us at www.rapidreinvent.com

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    MENS RAPID REINVENT 5 MINOXIDIL SOLUTION 
    minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83719-427
    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:83719-427-001 in 1 BOX10/16/2023
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623910/16/2023
    Labeler - THE SELF AND BODY LOVE COMPANY LLC (119082300)