Otc - Active Ingredient
Minoxidil 5% w/v
5% Minoxidil Topical Solution
FDA Label NDC 49539-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avacor Products, Llc for the product 5% Minoxidil Topical Solution (NDC 49539-001). 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, indications & usage, 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.
Label Section Quick Index
Otc - Purpose
Hair regrowth treatment
Indications & Usage
Use to regrow hair on the scalp
Warnings
For external use only, For use by men only.
Flammable: Keep away from fire or flame
Otc - Do Not Use
- 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, irritated or painful • you use other medicines on the scalp
Otc - Ask Doctor
Ask a doctor before use if you have heart disease
Otc - When Using
• 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.
Otc - Stop Use
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 of redness occurs
• unwanted facial hair growth occurs
• you do not see hair regrowth in 4 months
Otc - Pregnancy Or Breast Feeding
May be harmful if used when pregnant or breast-feeding.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Instructions For Use
Directions
• 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
Other Safety Information
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 age 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 USP controlled room temperature 20° to 25°C (68° to 77°F).
Inactive Ingredient
Inactive Ingredients: Alcohol, Propylene Glycol, Purified Water
Dosage & Administration
Directions
• 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
* Please review the disclaimer below.
