Active Ingredient
Minoxidil 5% w/w
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Earth Surface Trading Co., Ltd. for the product Minoxidil Hair Regrowth Treatment (NDC 85636-024). 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 if, when using, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 5% w/w
Hair Regrowth
Use to regrow hair of the scalp and beard growth for men and wemen
Warnings
For external use only.
Keep out of reach of children.
Do not use if
You have no family history of hair loss.
Your hair loss is sudden and/or patchy.
Your hair loss is associated with childbirth.
You do not know the reason for your hair loss.
You are under 18 years of age. Do not use on babies and children.
Your scalp is red, inflamed, infected, irritated, or painful.
You use other medicines on the scalp.
When Using
Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water.
Stop Use And Ask A Doctor
Chest pain, rapid heartbeat, faintness, or dizziness occurs.
Sudden, unexplained weight gain occurs.
Scalp irritation or redness occurs.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Keep Out Of Reach Of Children
Directions
Apply twice a day. Once in the morning and another time in the
evening before bed
Spray directly on top of the scalp in the area to be treated
Using more than directed or more often will not improve results
Continued use is necessary to lncrease and then malntain your
hair regrowth
Other information
Before use, read all information on carton and enclosed leaflet.
Store at controlled room temperature 10° to 30°C (50° to 80°F).
Do not incinerate container. Do not expose to heat or store at temperature above 104°F (40°C).
Water, Propylene Glycol, Potassium Sorbate, Castor Oil, Lavender Oil, Cymbopogon Citratus Leaf, Chamomile, Biotin , Rosemary Oil, Ginger, Batana Oil
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