Label: 5% MINOXIDIL SPRAY.- 5% minoxidil spray liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 20, 2023

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

  • Active Ingredient

    Minoxidil 5%

  • Purpose

    Hair Regrowth Treatment

  • 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

  • Do not use

    your amount of hair loss is different than that shown on side of this carton, or 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

    You have no family history of hair loss,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 it on babies and children

    scalp is red,inflamed,infected,irritated,or painful

    you use other medicines on th scalp

  • When Using

    Do not apply on other parts of the body

    avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount 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

    chest pain, rapid heart beat, 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

  • Ask Doctor

    When Pregnant or breast-feeding

    If you have heart desease

  • Keep Oot Of Reach Of Children

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

  • Directions

    Apply 5 sprays 2 times a day directly to the scalp in the hair loss area

    Using more than directed 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 the carton

    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 minoxidil topical aerosol 5% for men

    in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical aerosol 5% for men provided more hair regrowth than minoxidil topical aerosol 2%

    Store at 20 to 25°C (68 to 77°F). Keep tightly closed.

  • Inactive ingredients

    Deionized Water,Biotin, Rosemary Oil, Castor Oil, Panthenol, Niacinamide, Aloe Vera Extract, Ethanol, Glycerin

  • Questions

    customerservice@avitapure.com

  • PRINCIPAL DISPLAY PANEL

    0102

  • INGREDIENTS AND APPEARANCE
    5% MINOXIDIL SPRAY. 
    5% minoxidil spray liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83299-020
    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
    ALCOHOL (UNII: 3K9958V90M)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    WATER (UNII: 059QF0KO0R)  
    BIOTIN (UNII: 6SO6U10H04)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83299-020-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535711/01/2023
    Labeler - Consilii LLC (118891890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consilii LLC118891890label(83299-020) , manufacture(83299-020)