Label: HAIR REGEN HAIR GROWTH TREATMENT- minoxidil liquid

  • NDC Code(s): 84232-001-01
  • Packager: YIWU YIZHOU TRADING CO.,LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 8, 2024

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

  • Active Ingredient(s)

    Minoxidil 5% w/v

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    to regrow hair on top of scalp (vertex only, see pictures on side of box)

  • Warnings

    For external use only. For use by men only.FI ammable: Keep away from fire or flame

  • Do not use

    • You are a woman.
    • Your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% 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, rritated, or painful.
    • You use other medicines on the scalp.
  • When using this product.

    ●Do not apply on other parts of your body.

    ●Avoid contact with the eyes. In case 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 hai, 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 on all men,

  • Stop use

    ●Chest pain, rapid heartbeat, faintness, or dizziness occurs

    ●Sudden, unexplained weight gain occurs

    ●Your hands or feet swell

    ●Scalp rritation or redness ocurs

    ●Unwanted facial hair growth occurs

    ●You do not see hair growth in 4 months

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ●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 improve resufts.

    ●continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

  • Other information

    ●See hair loss pictures on side of box

    ●Before use, read all information on box and enclosed instructions.

    ●Keep the box, it contains important information.

    ●Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical sol ution 5% for men.

    ●In Clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical sol lution 2%

    ●Store at 20° to 25*C (68° to 77*F). Keep tightly closed

  • Inactive ingredients

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    HAIR REGEN HAIR GROWTH TREATMENT 
    minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84232-001
    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
    ALCOHOL (UNII: 3K9958V90M) 5.6 mL  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 61.9 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 27 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84232-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/09/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01604/09/2024
    Labeler - YIWU YIZHOU TRADING CO.,LTD (840905001)
    Establishment
    NameAddressID/FEIBusiness Operations
    YIWU YIZHOU TRADING CO.,LTD840905001manufacture(84232-001)