Label: WOMENS MINOXIDIL HAIR GROWTH SYSTEM- minoxidil liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 23, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Minoxidil 2% w/v

  • Purpose

    Hair Regrowth for women

  • Warnings

    For external use only.

    Flammable: Keep away from fire or flame

  • Use

    To regrow hair on the scalp

  • WARNINGS

    Do not use if

    • 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

    Ask a doctor before use if you have heart disease

    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

    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 of redness occurs
    • unwanted facial hair growth occurs

    May be harmful if used when pregnant or breast-feeding.

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

  • Directions

    Apply one mL 2 times a day directly onto the scalp in the hair loss area

    • see enclosed leaflet for complete Directions for Use
    • using more or more often will not improve result
    • continued use is necessary, or hair loss will begin again
  • Inactive Ingredients

    Alcohol, Propylene Glycol, Purified Water

  • Questions?

    Call Topiderm at 800-445-2595 or reach us on the internet at topiderm.com

  • STORAGE AND HANDLING

    Store at Controlled Room Temperature 20° to 25°C (68° to 77°F)

  • SPL UNCLASSIFIED SECTION

    Distributed By: Topiderm Inc., 5200 New Horizions Blvd. N. Amityville, NY 11701

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    COMPLIMENTS OF
    TOPIX
    PHARMACEUTICALS, INC

    WOMEN'S
    Minoxidil Hair Regrowth

    2% MINOXIDIL TOPICAL SOLUTION, USP
    HAIR REGROWTH TREATMENT

    Unscented

    Clinically proven to help regrow hair

    Reactivates hair follicles to
    stimulate regrowth

    Topical Solution

    One Month Supply 60 mL (2 fl oz)

    Available Custom Branded
    800.445.2595
    c.service@topixpharm.com

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    WOMENS MINOXIDIL   HAIR GROWTH SYSTEM
    minoxidil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-161-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07817603/26/2021
    Labeler - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456MANUFACTURE(51326-161)
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