Label: MENS MINOXIDIL HAIR GROWTH SYSTEM- minoxidil solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 23, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Minoxidil 5% w/v

  • Purpose

    Hair Regrowth for men

  • Warnings

    For external use only. For use by men only.

    Flammable: Keep away from fire or flame

    Use

    To regrow hair on the scalp

    Do not use if

    • you are a woman
    • 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 or 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

    MEN'S
    Minoxidil Hair Regrowth

    EXTRA STREGNTH
    5% MINOXIDIL
    TOPICAL SOLUTION, USP
    HAIR REGROWTH TREATMENT

    Reactivates Hair Follicles to Stimulate Regrowth
    Clinically Proven to Help Regrow Hair
    Topical Solution
    Unscented

    For Best Results:
    Apply Directly to Scalp. Use Twice Daily

    One Month Supply 60mL (2 fl oz)

    Available Custom Branded
    800.445.2595
    c.service@topixpharm.com

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MENS MINOXIDIL   HAIR GROWTH SYSTEM
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL50 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:51326-160-1660 mL in 1 BOTTLE; Type 0: Not a Combination Product03/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623903/23/2021
    Labeler - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topix Pharmaceuticals Inc613171433PACK(51326-160)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456MANUFACTURE(51326-160)
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