Otc - Active Ingredient
Minoxidil 5% w/v
The following Structured Product Label (SPL) was submitted to the FDA by Daniel Alain, Inc for the product Daniel Alain Extra Strength Hair Regrowth Treatment For Men (NDC 82545-002). 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 picture on side on carton)
For external use only. For use by men only.
Flammable Keep away from fire or flame.
Do not use if
Ask a doctor before use if you have heart disease
When using this product
Stop use and ask doctor if
May be harmful if used when pregnant or breast-feeding.
If swallowed, get medical help, or contact a Poison Control Center right away.
• Apply one mL with dropper 2 times a day directly 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.
• 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 68° to 77°F (20° to 25°C).
Alcohol, Propylene Glycol, Purified Water
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Visit website: www.danielalain.com
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