Label: HAIR ILLUSION 5% MINOXIDIL FOAM- minoxidil aerosol, foam

  • NDC Code(s): 83572-999-33, 83572-999-77
  • Packager: Hair Illusion
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 3, 2023

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

  • Drug Facts

  • Active ingredient

    Minoxidil 5% w/w

  • Purpose

    Hair regrowth treatment

  • Use

    • Minoxidil is used to stimulate hair growth and to slow balding.
    Minoxidil is a medication used for the treatment of hair loss. It stimulates hair growth and thickness where applied. Thus, minoxidil can be used for stimulation of beard growth in men.

  • Warnings

    For external use only. 

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

    Do not use if
    • 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 on babies and children.
    • scalp is red, inflamed, infected, irritated, or painful
    • you use other medicines on the scalp

    When using this product
    • Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
    • It takes time to regrow hair. You may need to use this product 2 times a day 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 and ask a doctor if
    • chest pain, rapid heart beat, faintness, or dizziness occurs
    • sudden, unexplained weight gain occurs
    • your hands or feet swell
    • scalp irritation or redness occurs
    • you get unwanted facial hair growth
    • you do not see hair regrowth in 4 months

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply one pump of the topical foam to the scalp in the area to be treated. Massage into the scalp with your fingers, then wash hands thoroughly.
    • Using more hair regrowth foam or using the foam more often will not improve your results.
    • Continued use is necessary to increase and then maintain your hair regrowth. Discontinuing use may result in hair loss.

    USING THE PRODUCT
    • Dispense on pump of topical foam onto dry fingers.
    • Spread the foam over the targeted regrowth area, massaging the foam into the scalp.
    • Thoroughly wash your hands after applying to the scalp.
    • Replace the cap to prevent the foam from drying out.

  • Other information

    • Before use, read all information on carton
    • Keep the carton. It contains important information.
    • Store at controlled room temperature 20° to 25° C (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° C)

  • INGREDIENTS:

    5% Minoxidil, Biotin, Aqua (Water), Propylene Glycol, Hyaluronic Acid, Cocamidopropyl Betaine, Keratin Amino Acids, Tocopherol (Vitamin C), Glycerin, Xanthan Gum, Capryloyl Silk Amino Acids, Allantoin, Aloe Barbadensis Leaf Extract, Citrus Paradisi (Grapefruit) Seed Extract, Polygonum Cuspidatum (Japanese Knotweed) Extract.

  • SPL UNCLASSIFIED SECTION

    HAIR REGROWTH TREATMENT

    Dermatologist Recommended Active Ingredient

    Easy to use FOAM

    REVITALIZES HAIR FOLLICLES

    with added BIOTIN

    Clinically Proven to Help Regrow Hair

    Not For Use By Women

    One Month Supply

    Three-Month Supply

    Hair Illusion Hair Regrowth Treatment is formulated with a unique blend including 5% Minoxidil and Biotin for revitalizing hair follicles, treating thinning hair, receding hairlines, mild to moderate male pattern baldness and general hair loss. The easy to apply foam is suitable for all hair types and textures.

    For best results:
    • Apply Twice Daily
    • Apply Directly to Scalp

    100% SATISFACTION GUARANTEED

    Hair Illusion Inc.
    20725 N.E. 16th Ave
    Unit A44
    Miami FL 33179

    www.Hairillusion.com

  • Packaging

    HairIllusion-999HairIllusion-999

  • INGREDIENTS AND APPEARANCE
    HAIR ILLUSION 5% MINOXIDIL FOAM 
    minoxidil aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83572-999
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BIOTIN (UNII: 6SO6U10H04)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    HAIR KERATIN AMINO ACIDS (UNII: G46579QK1M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    REYNOUTRIA JAPONICA WHOLE (UNII: 1VDG5Y5HS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83572-999-331 in 1 BOX10/24/2023
    160 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:83572-999-773 in 1 BOX11/03/2023
    260 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/24/2023
    Labeler - Hair Illusion (095396416)