Active Ingredient
MINOXIDIL 5%
5% Minoxidil Hair Growth
FDA Label NDC 84033-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Qingdao Kuajie Online Electronic Technology Co., Ltd for the product 5% Minoxidil Hair Growth (NDC 84033-002). 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 active ingredient, purpose, how to use, warnings, stop use and ask a doctor if, do not use if, when using this product, storage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hair Growth
How To Use
Apply 1 ML(few drops)directly onto scalp on the hair loss area.
Use fingertips to massage solution into skin/hair for 2-3 minutes or use a roller to roll 4-5 times.
Allow time for hair to fully absorb Growth Oil, don't apply anything to your hair for a few hours.
Warnings
For external use only. For use by men only.
Flammable : Keep away from fire or flame.
Keep out of reach of children.
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
Do Not Use If
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, infected, irritated, or painful.
you use other medicines on the scalp.
Ask a doctor before use if you have heart disease.
May be harmful if used when pregnant or breast-feeding.
When Using This Product
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.
Storage
Store in a dark, cool place.
Store at controlled room temperature 59°F-77°F(15°C-25°C).
Keep out of direct sunlight.
Keep the cap on tightly when not in use.
Keep Out Of Reach Of Children
Flammable : Keep away from fire or flame.
Keep out of reach of children.
Dosage
Apply 1 ML(few drops)directly onto scalp on the hair loss area.
Use fingertips to massage solution into skin/hair for 2-3 minutes or use a roller to roll 4-5 times.
Allow time for hair to fully absorb Growth Oil, don't apply anything to your hair for a few hours.
Inactive Ingredient
WATER 81%
ZINGIBERENSIS SAPONIN I 0.6%
PANAX GINSENG ROOT OIL 0.6%
BIOTIN 1%
ROSMARINUS OFFICINALIS FLOWERING TOP OIL 0.5%
VITAMIN D5 0.1%
1.2-BUTANEDIOL 5%
ARGAN OIL 0.6%
GLYCERIN 5%
HYALURONIC ACID 0.1%
PHENOXYETHANOL 0.5%
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