Label: MENS ROGAINE MINOXIDIL - UNSCENTED FORMULA- minoxidil aerosol, foam

  • NDC Code(s): 69968-0031-1, 69968-0031-3, 69968-0031-4
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated March 9, 2016

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.

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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 booklet 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 package and enclosed booklet
    • keep the package. 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

    butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane, lactic acid, polysorbate 60, propane, purified water, SD alcohol40-B, stearyl alcohol

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  • Questions?

    • call toll-free 800-ROGAINE or 215-273-8755 (collect)
    • visit www.rogaine.com
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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558

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  • PRINCIPAL DISPLAY PANEL - Three 60 g Can Package

    #1 DERMATOLOGIST RECOMMENDED BRAND

    MEN'S
    Rogaine®

    5% MINOXIDIL TOPICAL AEROSOL
    HAIR REGROWTH TREATMENT

    REVITALIZES
    HAIR FOLLICLES
    EASY-TO-USE
    FOAM

    CLINICALLY PROVEN TO HELP REGROW HAIR

    UNSCENTED
    Not For Use By Women
    Three Month Supply Three 60 g (2.11 oz) Cans

    Principal Display Panel - Three 60 g Can Package
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  • INGREDIENTS AND APPEARANCE
    MENS ROGAINE MINOXIDIL   - UNSCENTED FORMULA
    minoxidil aerosol, foam
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0031
    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
    Butane (UNII: 6LV4FOR43R)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isobutane (UNII: BXR49TP611)  
    Lactic Acid, Unspecified Form (UNII: 33X04XA5AT)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Propane (UNII: T75W9911L6)  
    Water (UNII: 059QF0KO0R)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69968-0031-1 1 in 1 PACKAGE
    1 60 g in 1 CAN; Type 0: Not a Combination Product
    2 NDC:69968-0031-3 3 in 1 PACKAGE
    2 60 g in 1 CAN; Type 0: Not a Combination Product
    3 NDC:69968-0031-4 4 in 1 PACKAGE
    3 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
    NDA NDA021812 10/01/2010
    Labeler - Johnson & Johnson Consumer Inc. (002347102)
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