Active Ingredient
5% Minoxidil
Fidyn 5% Minoxidil Hair Growth Serum For Men
FDA Label NDC 83912-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fidyn 5% Minoxidil Hair Growth Serum For Men for the product Fidyn 5% Minoxidil Hair Growth Serum For Men (NDC 83912-001). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hair regrowth treatment
Use
to regrow hair on the scalp
Warnings
For external use only
Do Not Use
- If you have hair loss suddenly or patchy or both.
- You are under 18 years of age. Do not use it on babies and children.
- The scalp becomes red, inflamed, infected, inflamed, and painful.
- You are using other medicines on your scalp.
When Using
- Avoid making eye contact. In case of accidental eye contact, flush your eyes with copious amounts of cold tap water.
Stop Use
- Chest pain, rapid heart rate, fainting, and dizziness.
- Sudden unexplained weight gain.
- Your hands or feet swell.
- Inflammation and redness of the scalp occur.
- Unwanted hair grows on your face, after 4 months, the hair will stop growing.
Ask Doctor
- Chest pain, rapid heart rate, fainting, and dizziness.
- Sudden unexplained weight gain.
- Your hands or feet swell.
- Inflammation and redness of the scalp occur.
- Unwanted hair grows on your face, after 4 months, the hair will stop growing.
Keep Oot Of Reach Of Children
‘If swallowed, get medical help or contact a poison control center right away.
Directions
- 1 ml each time (containing 50 mg of minoxidil), apply to the affected area of the scalp, 2 times a day.
- Starting from the center of the affected area, and massage with fingertips for 3-5 minutes.
- Use this dose regardless of the size of the affected area.
- The total daily dosage should not exceed 2 ml.
- This product should be used when the scalp is completely dry.
- Please wash your hands immediately after using this product.
Other Information
- Read all information on the pack before use.
- Save the box. Contains important information.
- Store at controlled room temperature 20-25℃（68-77℉）
- Content under pressure. Do not puncture or burn the container. Do not expose to heat or store above 120℉(9℃)
Inactive Ingredients
Propylene Glycol, Water
Questions
If you have any questions or concerns, please contact us at [email protected]
Principal Display Panel
1 (Label)
* Please review the disclaimer below.
