Active Ingredient
Minoxidil 5% w/v
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xinxin Yunhai Technology Co., Ltd. for the product Veraroot Minoxidil Topical Solution (NDC 83818-033). 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
Hair regrowth treatment
regrows hair on the scalp
For external use only
Flammable: keep away from fire or flame
■ if you are a woman
■ if you have no family history of hair loss
■ if hair loss is sudden or patchy
■ if scalp is red, inflamed, infected, irritated, or painful
■If you don’t know the reason for your hair loss
■If you are under 18 years of age. Do not use on babies and children.
■If you use other medicines on the scalp.
■If your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp.
5% minoxidil topical solution is not intended for frontal baldness or receding hairline.
■ do not apply on other parts of the body
■ avoid contact with eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
■some people have experienced changes in hair color and/or texture.
■It takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product 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 all men.
Stop use and ask a doctor if
Scalp irritation or redness occurs
Unwanted facial hair growth occurs
You do not see hair regrowth in 4 months
Your hands or feet swell
Sudden, unexplained weight gain occurs
Chest pain, rapid heartbeat, faintness, or dizziness occurs
before use if you have heart disease
If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)
■ apply 1 mL with dropper 2 times a day directly onto 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
■ see hair loss pictures on carton
■ store at 20°–25°C (68°–77°F)
■ keep tightly closed
■ before use, read all information on carton
alcohol, propylene glycol, purified water
Contact [email protected]
* Please review the disclaimer below.