Label: SUAVECITO 5% MINOXIDIL SOLUTION- minoxidil liquid

  • NDC Code(s): 74866-414-01, 74866-414-03
  • Packager: SUAVECITO, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 18, 2023

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  • 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 women 
    • your amount of hair loss is different than that shown on the side of this carton 
    • your hair loss is on the front of the scalp. Minoxidil Topical Solution 5% 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, infected, 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.

    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 hair loss area
    • using more or more often will no improve results
    • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
  • Other information

    • Store at Controlled Room Temperature 20º to 25ºC (68º to 77ºF)
    • 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
  • Inactive Ingredients

    Alcohol, Propylene Glycol, Purified Water

  • Questions or comments?

    call toll-free phone number (714) 388-6920 or reach us online at website www.suavecto.com

  • Package Labeling:1 COUNT

    Label
  • Package Labeling:3 COUNT

    Label2

  • INGREDIENTS AND APPEARANCE
    SUAVECITO 5% MINOXIDIL SOLUTION 
    minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74866-414
    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:74866-414-011 in 1 BOX07/31/2023
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:74866-414-033 in 1 BOX07/31/2023
    260 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623907/31/2023
    Labeler - SUAVECITO, INC. (078681797)
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