Active Ingredient
Minoxidil 5% w/v (without propellant)
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Jianyuan Biological Technology.co.,ltd for the product Profolix Minoxidil Hair Growth Serum (NDC 81653-009). 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, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 5% w/v (without propellant)
Hair Regrowth Treatment For Scalp and beard Only
To Regrow hair, For Scalp and beard Only
Keep away from kids.
for external use only
Flammable: Keep away from fire or flame
If swallowed, seek medical help, or contact poison control.
Store at controlled room temperature 20 to 25 ° C (68 to 77 ° F)
Do not expose to heat or store at temperature above 49 ° C (120 ° F)
Avoid fire, flame, or smoking during and immediately following application.
your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
No family history of hair loss
Sudden or patchy hair loss
Unknown cause of hair loss
Under 18 years old (Avoid use on babies and children).
Red, inflamed, infected, irritated, or painful scalp.
Use of other scalp medications
May be harmful if used when pregnant or breast - feeding.
Apply only on the scalp or beard
Avoid contact with eyes (Rinse with cool water if contact occurs)
Experience chest pain, rapid heartbeat, faintness, or dizziness
Sudden, unexplained weight gain
Swelling of hands or feet
Scalp irritation or redness
Unwanted facial hair growth
No hair regrowth after 4 months
If have Allergy, plz check with doctor
Keep Oot Of Reach Of Children
Roll the roller gently across the treated scalp area, 5-10 times, in horizontal, vertical, and diagonal motions.
Apply 2-3 drops to the treated scalp area.
Massage in with fingers and wash hands thoroughly.
More serum or frequent use won't enhance results.
Consistent use is key for hair regrowth. Stopping may lead to hair loss.
Results may take at least 4 months with daily use (recommended: men: Once daily, Women: Twice daily)
Effectiveness varies from person to person.
The hair growth cycle is around 6 months. Consistent use is crucial for effectiveness, and visible results may appear after 3-4 months. Keep up the treatment post-initial improvements to sustain progress; discontinuation may lead to withdrawal.
Water, Alcohol, Ginseng Extract, Ginger Extract, Carthamus Tinctorius L. Extract, Cortex Dictamni, Fructus Ligustri Lucidi Extract, Ligusticum Chuanxiong Hort Extract, Glycyrrhiza Uralensis Fisch Extract, Arctium Lappa L., Angelica Sinensis, Cacumen Platycladi Orientalis P.E., Polygonum Multiflorum Thunb, Capsaicin, Vitamin H (Biotin), Collagen.
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