Otc - Active Ingredient
Minoxidil 5% w/v
The following Structured Product Label (SPL) was submitted to the FDA by Ds Healthcare Group, Inc. for the product Mens Spectral Uhp Extra Strength Hair Regrowth Treatment (NDC 69188-001). 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 otc - active ingredient, otc - purpose, use, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 5% w/v
Hair regrowth treatment for men
to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
For external use only. For use by men only.
Flammable: Keep away from fire or flame
Do not use if
■ You are a woman
■ Your amount of hair loss is dierent than that shown on the side of this carton, or your hair loss is on the front of the scalp.
Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
■ You have no family history of hair loss
■ Your hair loss is sudden and/or patchy
■ 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
Ask a doctor before use if you have heart disease
When using this product
■ Do not apply on other parts of the body
■ Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
■ 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.
■ Some people have experienced changes in hair color and/or texture
Stop use and ask a doctor if
■ Chest pain, rapid heartbeat, faintness, or dizziness occurs
■ Sudden, unexplained weight gain occurs
■ Your hands or feet swell
■ Scalp irritation or redness occurs
■ Unwanted facial hair growth occurs
■ You do not see hair regrowth in 4 months
May be harmful if used when pregnant or breast-feeding.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
of full spray. Do not inhale mist.
• see hair loss pictures on side of this carton
• before use, read all information on carton and enclosed leaflet
• keep the carton. It contains important information.
• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with
continuous treatment with 5% minoxidil topical solution for men • in clinical studies of mostly
white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution
for men provided more hair regrowth than 2% minoxidil topical solution
• store at controlled room temperature 20° to 25°C (68° to 77°F)
alcohol, propylene glycol, purified water
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