Label: FIDYN 5% MINOXIDIL HAIR GROWTH SERUM FOR MEN- 5% minoxidil hair growth serum for men liquid

  • NDC Code(s): 83912-001-01
  • Packager: Fidyn 5% Minoxidil HAIR GROWTH SERUM For Men
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 23, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    5% Minoxidil

  • 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 Fidyn@yeah.net

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    FIDYN 5% MINOXIDIL HAIR GROWTH SERUM FOR MEN 
    5% minoxidil hair growth serum for men liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83912-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    WATER (UNII: 059QF0KO0R)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83912-001-0130 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package12/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07535712/22/2023
    Labeler - Fidyn 5% Minoxidil HAIR GROWTH SERUM For Men (722806041)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanjing Shangfu International Trade Co., Ltd.722806041manufacture(83912-001) , label(83912-001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!