Label: MINOXIDIL 5% (FOR MEN)- minoxidil aerosol, foam

  • NDC Code(s): 51672-2128-4, 51672-2128-9
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 27, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Minoxidil 5% w/w (without propellant)

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  • Purpose

    Hair regrowth treatment for men

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  • Use

    to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)

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  • Warnings

    For external use only.

    For use by men only.

    Extremely Flammable

    Avoid fire, flame, or smoking during and immediately following application.

    Do not use if

    • you are a woman
    • your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam 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, 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
    • it takes time to regrow hair. 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 for all men.

    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 or redness occurs
    • unwanted facial hair growth occurs
    • you do not see hair regrowth in 4 months

    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. (1-800-222-1222)

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  • Directions

    • apply half a capful 2 times a day to the scalp in the hair loss area
    • massage into scalp with fingers, then wash hands well
    • see enclosed leaflet for complete directions on how to use
    • using more or more often will not improve results
    • continued use is necessary to increase and keep your hair regrowth or hair loss will begin again
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  • Other information

    • hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months
    • see hair loss pictures on side of this carton
    • before use, read all information on carton and enclosed leaflet
    • keep the carton. It contains important information.
    • store at controlled room temperature 20° to 25°C (68° to 77°F)
    • contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120°F (49°C).
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  • Inactive ingredients

    butylated hydroxytoluene, cetyl alcohol, citric acid anhydrous, dehydrated alcohol, isobutane, lactic acid, n-butane, polysorbate 60, propane, purified water, stearyl alcohol

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  • Questions?

    • Call 1-866-923-4914
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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

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  • PRINCIPAL DISPLAY PANEL - 60 g Can Carton

    *Compare to the active
    ingredient of
    Men's Rogaine®

    NDC 51672-2128-4

    Minoxidil
    Topical Aerosol,
    5% (For Men)

    Easy-to-use
    foam

    UNSCENTED

    HAIR REGROWTH
    TREATMENT

    REVITALIZES
    HAIR
    FOLLICLES

    Not For Use By Women

    One Month Supply

    One 60 g (2.11 oz) Can

    Principal Display Panel - 60 g Can Carton
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  • INGREDIENTS AND APPEARANCE
    MINOXIDIL   5% (FOR MEN)
    minoxidil aerosol, foam
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2128
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1) Minoxidil 50 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    cetyl alcohol (UNII: 936JST6JCN)  
    anhydrous citric acid (UNII: XF417D3PSL)  
    alcohol (UNII: 3K9958V90M)  
    isobutane (UNII: BXR49TP611)  
    lactic acid, unspecified form (UNII: 33X04XA5AT)  
    butane (UNII: 6LV4FOR43R)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    propane (UNII: T75W9911L6)  
    water (UNII: 059QF0KO0R)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    Product Characteristics
    Color WHITE (white to off-white foam) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51672-2128-4 1 in 1 PACKAGE 01/02/2019
    1 60 g in 1 CAN; Type 0: Not a Combination Product
    2 NDC:51672-2128-9 3 in 1 PACKAGE 01/02/2019
    2 60 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA209074 01/02/2019
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(51672-2128)
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