Label: HAIRFX HAIR GROWTH FOAM- minoxidil aerosol, foam

  • NDC Code(s): 81653-003-01
  • Packager: Guangzhou Jianyuan Biological Technology.Co.,Ltd
  • Category: HUMAN OTC DRUG LABEL

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 December 19, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    Minoxidil 5%

  • PURPOSE

    STRONGER THICKER LONGER HAIR
    REDUCE HAIR LOSS
    RESTORE THINNING HAIR
    The Foam is for somepeople who have a general thinning of hair on the top of the scalp(vertex only, asshown below). Not intendedfor frontal baldness or areceding hairline. The Foamhas been shown to regrowhair in some people with thefollowing degrees of thinninghair or hair loss.

    1122
    lf you have more hair loss or hair loss in a place different than shown above, Foam may not work.

  • lnactive ingredients

    Water, Vitamin H (Biotin), Pork Collagen. Panax Ginseng Berry Extract, Carthamus Tinctorius (Safflower) Flower Extract, Frangula Alnus Bark Extract, Ligustrum Lucidum Fruit Extract, Ligusticum Chuanxiong Root Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Angelica Sinensis Root Extract, Platycladus Orientalis, Polygonum Multiflorum Root Extract, Capsaicin

  • INDICATIONS & USAGE

    for hair loss

    Apply half a capful once daily to directly to the scalp in the hair loss area massage into scalp with fingers. then wash hands well.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

  • KEEP OUT OF REACH OF CHILDREN

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

  • WARNINGS

    For adult external use only. Flammable. Keep away fromheat or flame.
    Do not use
    ·Pregnant women and children.
    ·on open skin wounds

  • WARNINGS AND PRECAUTIONS

    When using this product keep out of eyes, ears, andmouth. In case of contact with eyes, rinse eyes thoroughlywith water.
    Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition.

  • ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

    USING THE PRODUCT
    To open container.
    The foam may begin to melt right away on contact with your
    warm skin. If your fingers arewarm, rinse them in cold water first.(Be sure to dry them thoroughly before handing thefoam.)
    Press nozzle to dispense the topical foam product onto your fingers. The total amount of foam applied should not exceed half a capful.
    Using your fingers, spread the foam over the hair loss area
    and gently massage into scalp and then wash your hands well. After each use, dose the container to make child resistant by snapping the cap back on to the can.

  • other information

    Store at Controlled Room Temperature 20 °C to25 °C(68°Fto 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).

    Don't hold straight upside down

  • STOP USE

    Do not use
    - Pregnant women and children.
    - on open skin wounds
    when using this product
    keep out of eyes,ears, and mouth. ln case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor
    if irritation or rashoccurs.These may be signs of a serious condition.
    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison ControlCenter right away.

  • DOSAGE & ADMINISTRATION

    THIS PACKAGE CONTAINS. One 60g (2.11 fl oz) cans of Foam (one month supply)

    Apply half a capful once daily to directly to the scalp in the hair loss area massage into scalp with fingers

  • PRINCIPAL DISPLAY PANEL

    60g

  • INGREDIENTS AND APPEARANCE
    HAIRFX HAIR GROWTH FOAM 
    minoxidil aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81653-003
    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
    WATER (UNII: 059QF0KO0R)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOT (UNII: RR83T99U97)  
    LIGUSTRUM LUCIDUM FRUIT (UNII: M9G2U96DUT)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    CAPSAICIN (UNII: S07O44R1ZM)  
    BIOTIN (UNII: 6SO6U10H04)  
    PORK COLLAGEN (UNII: I8442U2G7J)  
    PANAX GINSENG FRUIT (UNII: E35T4MOI3E)  
    FRANGULA ALNUS BARK (UNII: S2D77IH61R)  
    GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)  
    PLATYCLADUS ORIENTALIS WHOLE (UNII: 835370K47L)  
    REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81653-003-0160 g in 1 BOTTLE; Type 0: Not a Combination Product03/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/23/2022
    Labeler - Guangzhou Jianyuan Biological Technology.Co.,Ltd (548120189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Jianyuan Biological Technology.Co.,Ltd548120189manufacture(81653-003)