Active Ingredient
Minoxidil 5%
Hairfx Hair Growth Foam Aerosol, Foam
FDA Label NDC 81653-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Jianyuan Biological Technology.co.,ltd for the product Hairfx Hair Growth Foam (NDC 81653-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, otc - purpose, lnactive ingredients, indications & usage, keep out of reach of children, warnings, warnings and precautions, route, method and frequency of administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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 (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
Otc - 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
* Please review the disclaimer below.
