Otc - Active Ingredient
Minoxidil 5%
The following Structured Product Label (SPL) was submitted to the FDA by Lianjiang Shanlilai E-commerce Co., Ltd. for the product Minoxidil Hair Regrowth Solution (NDC 85038-007). 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 - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Minoxidil 5%
Hair regrowth treatment
Uses to regrow hair on the top of the scalp
For external use only.
Flammable: Keep away from fire or flame
your degree of hair loss is different than that shown on side of this carton ,because this product may not work for you.
you have no family history of hair loss.
your hairloss is sudden and/or patchy.
your hairloss 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 and children.
your scalp is red,inflamed,infected,irritated, or painful.
you use other medicines on the scalp.
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. You may need to use this product 2 times a day for at least 4 monthspefore you see results.
the amount of hair regrowth is diferent for each person. This product will not work for everyone
chest pain,rapid heartbeat,faintness, or dizziness occurs.
sudden, unexplained weight gain occurs.
your hands or feet swel.
scalp irritation or redness occurs.
unwanted facial hair growth occurs.
you do not see hair regrowth in 4 months
Keep out of reach of children. lfswallowed, get medical help or contact a Poison Control Centerright away.(1-800-222-1222)
apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area.
massageinto scalp with fingers, then wash hands well.
using more or more often will notimprove results.
continued use is necessary to increase and keep your hair regrowth or hair loss will begin again.
biotin
castor oil
alcohol
glycerin
cetyl alcohol
lactic acid
water
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