Label: MINOXIDIL HAIR GROWTH FOAM aerosol, foam

  • NDC Code(s): 84315-001-01
  • Packager: Guangzhou Yibai Technology Sarl
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 8, 2024

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

  • ACTIVE INGREDIENT

    Minoxidil 5% w/w (without propellant)

    Diaminopyrimidine oxide 3%

  • PURPOSE

    Hair regrowth treatment

    Treat hair loss caused by premature loss of hair roots

  • INDICATIONS & USAGE

    Treatment of hair loss and alopecia areata

  • WARNINGS

    For external use only.

    Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

  • DO NOT USE

    You are allergic to any of the ingredients

    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

    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 one, 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 notwork for all.

  • 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 or redness occurs.

    Unwanted facial hair growth occurs.

    You do not see hair regrowth in 4 months.

  • KEEP OUT OF REACH OF CHILDREN

    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(1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Apply evenly to hair loss areas twice a day and massage scalp for 1-2 minutes until absorbed,then wash hands well.See enclosed leaflet for complete directions how to use.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

  • STORAGE AND HANDLING

    Store at controlled room temperature 20° to 25℃ (68° to 77°F) Contents under pressure.

    Do not puncture or incinerate container.

    Do not expose to heat or store at temperatures above 120°F (49℃)

  • INACTIVE INGREDIENT

    1.2-propylene glycol 37%, ethanol 25%, water 30%

  • PRINCIPAL DISPLAY PANEL

    84315-001-01

  • INGREDIENTS AND APPEARANCE
    MINOXIDIL HAIR GROWTH FOAM 
    minoxidil hair growth foam aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84315-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIAMINOPYRIMIDINE OXIDE (UNII: 1756681479) (DIAMINOPYRIMIDINE OXIDE - UNII:1756681479) DIAMINOPYRIMIDINE OXIDE3 g  in 100 g
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84315-001-0160 g in 1 CANISTER; Type 0: Not a Combination Product05/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535705/09/2024
    Labeler - Guangzhou Yibai Technology Sarl (281523247)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Yibai Technology Sarl281523247manufacture(84315-001)