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5% Minoxidil Hair Regrowth Solution With Biotin
5% Minoxidil Hair Regrowth Solution With Biotin
FDA Label NDC 83767-301
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ruijiu Electronic Technology Co., Ltd. for the product 5% Minoxidil Hair Regrowth Solution With Biotin (NDC 83767-301). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, 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 - Active Ingredient
Minoxidil 5%
Biotin 0.2%
Otc - Purpose
Hair Regrowth
Indications & Usage
Use to regrow hair of scalp and beard
Warnings
For external use only.
Keep out of reach of children.
Otc - Do Not Use
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 and children
Your scalp is red,inflamed, infected, irritated, or painful.
You use other medicines on the scalp.
Otc - When Using
Avoid contact with eyes. In case of accidental contact, rinse eyes with alarge amount of cool tap water.
You need to use this product 1 times a day for at least 3 months beforeyou see results, The amount of hair regrowth is different for each person.
Otc - Stop Use
Ifscalp irritation or redness occurs.
lf you get unwanted facial hair growth.
lf you do not see hair regrowth in 4 months.
lf sudden, unexplained weight gain occurs.
Otc - Keep Out Of Reach Of Children
lf swallowed, get medical help or contact a Poison Control Center
(1-800-222-1222)right away.
Dosage & Administration
Apply 1 ml of Minoxidil Serum directly onto the scalp in the hair loss area.
Use fingertips to massage solution into skin/hair for 1 minutes thenwashhands thoroughly.
Men: use twice daily.Women: use once daily on clean, dry hair for best results.
Storage And Handling
Before use, read all information on carton and enclosed leaflet Storeat controlled room temperature 10° to 25°C (50° to 77°F)
Do not incinerate container. Do not expose to heat or store attemperature above 104°F(40°C).
Inactive Ingredient
CASTOR OIL
ALCOHOL
GLYCERIN
CETYL ALCOHOL
LACTIC ACID
WATER
Package Label.Principal Display Panel
Label1 (Label 1)
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Label3 (Label 3)
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