Otc - Active Ingredient
MINOXIDIL 5%
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Shandian Jingling Technology Co., Ltd. for the product Hair Growth Foam (NDC 83804-008). 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
to regrow hair on the top of the scalp
For external use only.
Flammable: Keep away from fire or flame
you have no family history of hair loss
your hair loss is sudden and/or patchy
you do not know the reason for yourhair loss
you are under 18 years of age. Do notuse on babies and children
your scalp is red, inflamed, infectedirritated 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 chan-ges in hair color and/or texture
it takes time to regrow hair. Results may occur at 2 months with twice a day us-age. For some men, you may need to use this product for at least 4 months before you see results
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
If swallowed,get medical help or con-tact a Poison Control Center right away.(1-800-222-1222)
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 im-prove results
continued use is necessary to incre-ase and keep your hair regrowth, or hair loss will begin again
water
minoxidil
glycerin
butylene
glycol
niacinamide
capilia longa biota orientalis leaf extract
polygonum multiflorumextract
ligustrum lucidum fruit
extractligusticum chuanxiong root
extract zanthoxylum bungeanum
fruit extract 3-o-ethylascorbic acid
rosa canina fruit oil
sodium cocoyl glycinate
biotin
panthenol
caffeine
sodium hyaluronate
diso-dium edta
hydroxyacetophenone
1.2-nexanedi0l
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