Rootvive Mens Hair Regrowth Treatment Extra Strength Minoxidil Solution
FDA Label NDC 87663-962

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trueroot Labs Llc for the product Rootvive Mens Hair Regrowth Treatment Extra Strength Minoxidil (NDC 87663-962). 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 drug facts, active ingredient, purpose, use, warnings, do not use if:, ask a doctor before use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men

Use

to regrow hair on the top of the scalp (vertex only, see picture on side of carton)

Warnings

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 different than that shown on the 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
• 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 medicine 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 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 grow 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 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

Keep Out Of The Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply one mL with dropper 2 times a daydirectly onto the scalp in the hair loss area • 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

Other Information

• 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 growth than 2% minoxidil topical solution • store at controlled room temperature 20° to 25°C (68° to 77°F)

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments?

(346) 202-2858
Visit Website at www.shoprootvive.com

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