Label: GAINEXTRA HAIR REGROWTH TREATMENT FOR MEN 5%- minoxidil 5% spray

  • NDC Code(s): 82429-261-10
  • Packager: Gabar Health Sciences Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 21, 2023

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

  • ACTIVE INGREDIENT

    Minoxidil 5% w/v

  • PURPOSE

    Hair regrowth treatment for men

  • USE

    Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

  • WARNINGS

    For external use only

    Flammable: Keep away from fire or flame

  • DO NOT USE

    Do not use if

    ■ you are a woman

    ■ your amount of hair loss is dierent 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, 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

    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 everyone.

  • STOP USE

    ■ 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

  • 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

    ■ Prim the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.

    ■ apply one mL (6 sprays) 2 times a day directly onto the scalp in the area of hair loss

    ■ 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 this 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 18-19 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 between 68°-77°F (20°-25°C).

  • INACTIVE INGREDIENT

    alcohol, propylene glycol, purified water

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    GAINEXTRA HAIR REGROWTH TREATMENT FOR MEN 5% 
    minoxidil 5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82429-261
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82429-261-101 in 1 BOX10/23/2023
    1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623910/23/2023
    Labeler - Gabar Health Sciences Corp. (118401847)