Otc - Active Ingredient
Minoxidil 2% w/v
The following Structured Product Label (SPL) was submitted to the FDA by United Distribution Of Md, Llc for the product Navi Hair Solutions Womens Hair Regrowth Treatment (NDC 82524-001). 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 2% w/v
Hair regrowth treatment
Use to regrow hair on the top of the scalp
For external use only.
Flamable: Keep away from fire of flame.
Do not use if:
Your amount of hair loss is different than shown on the side of this carton, because this product may not work for you
You have no family history of hair loss
Your hair loss is sudden and/or patchy
Your hair loss is associated with childbirth
You do not know the reason for your hair loss
You are under 18 years of age. Do not use on babies or 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
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.
Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area
Using more or more ofthen 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 the side of this carton
Before use, read all information on carton and enclosed leaflet
Keep the carton. It contains important information
In clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the following responses to Minoxidil Topical Solution 2% was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal hair regrowth). This compares with the 7% of women reporting moderate hair regrowth after using a placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
Store at controlled room temperature 20 o to 25 o C (68 o to 77 oF)
Alcohol, Propylene Glycol, Purified Water
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