Foligain Professional Series Extra Strength For Men Minoxidil Hair Regrowth Treatment Solution
FDA Label NDC 69607-9540
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wr Group, Inc. for the product Foligain Professional Series Extra Strength For Men Minoxidil Hair Regrowth Treatment (NDC 69607-9540). 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 you:, 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.
Label Section Quick Index
Active Ingredient
Minoxidil 5% w/v
Purpose
Hair regrowth treatment for men
Use
to regrow hair on the scalp. (vertex only, see picture on side of carton)
Warnings
For external use only. For use by women only. Flammable:Keep away from fire or flame.
Do Not Use If You:
• are a woman.
• have hair loss other than that shown on the side of this carton, because this product may not work for you.
• have no family history of hair loss.
• have sudden and/or patchy hair loss.
• do not know the reason for your hair loss.
• are under 18 years of age.
• have a red, inflamed, infected, irritated or painful-feeling scalp.
• 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.
• 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 You Experience:
• chest pain, rapid heartbeat, faintness, or dizziness.
• sudden, unexplained weight gain.
• swelling of the hands or feet.
• scalp irritation or redness.
• unwanted facial hair growth.
• no hair regrowth in 4 months.
May Be Harmful If Used When Pregnant Or Breastfeeding.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Apply 1 mL with dropper two (2) times a day directly onto the scalp in the hair loss area.
• Using more product, or using product 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 regrowth 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?
• call us at +1 (844) 473-7279
• visit www.foligain.com
* Please review the disclaimer below.
