MENS ALOPEXY (MINOXIDIL) SOLUTION [GENESIS PHARMACEUTICAL, INC.]

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MENS ALOPEXY (MINOXIDIL) SOLUTION [GENESIS PHARMACEUTICAL, INC.]
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NDC 64760-602-01, 64760-602-03
Set ID 0f2d5d29-b304-483a-bdfe-2e910673957b
Category HUMAN OTC DRUG LABEL
Packager Genesis Pharmaceutical, Inc.
Generic Name
Product Class Arteriolar Vasodilator
Product Number
Application Number ANDA076239
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  • Drug Facts

  • Active Ingredient

    Minoxidil USP 5% w/v

  • Purpose

    Hair regrowth treatment for men

  • Use

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

  • Warnings

     For external use only

    For use by men only

    Flammable: Keep away from fire or flame

    Do not use if

    • 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, 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.

  • Directions

    • prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
    • apply 1 ml with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area
    • 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
  • Other Information

    • 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.
    • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with Minoxidil Topical Solution, 5%
    • in clinical studies with mostly white men age 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution, 5% for men provided more hair regrowth than Minoxidil Topical Solution, 2%
    • store at controlled room temperature 20º to 25ºC (68º to 77ºF)
  • Inactive Ingredients

    Alcohol, Propylene Glycol, Purified Water

  • Questions or Comments?

    Call your health professional or Pierre Fabre at 1-800-459-8663. Monday – Friday: 9:00 AM – 5:00 PM (EST)

  • PRINCIPAL DISPLAY PANEL - Three - 60 mL Bottles Carton

    NDC 64760-602-03

    DUCRAY

    LABORATOIRES DERMATOLOGIQUES

    MEN’S

    alopexy

    minoxidil topical solution USP, 5 %

    hair regrowth treatment

    EXTRA STRENGTH FOR MEN

    Reactivates Hair Follicles To Stimulate Regrowth

    Clinically Proven To Help Regrow Hair

    Topical Solution

    Unscented

    NOT FOR USE BY WOMEN

    Three Month Supply

    Three - 60 mL (2 FL. OZ.) Bottles

    MENS Alopexy 5% - 3 month supply carton

    MENS Alopexy 5% - 3 month supply carton

    MENS Alopexy 5% - 3 month supply carton

    MENS Alopexy 5% - 3 month supply carton

  • INGREDIENTS AND APPEARANCE
    MENS ALOPEXY 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-602
    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:64760-602-033 in 1 CARTON08/08/2016
    1NDC:64760-602-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623908/08/2016
    Labeler - Genesis Pharmaceutical, Inc. (117196928)
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