REGEN (5% MINOXIDIL TOPICAL SOLUTION) SOLUTION [PREMIUM DISTRIBUTION, LLC]

REGEN (5% MINOXIDIL TOPICAL SOLUTION) SOLUTION [PREMIUM DISTRIBUTION, LLC]
PDF | XML

NDC 70788-580-01
Set ID bffed457-967a-4afb-87c9-3e4e1285f04d
Category HUMAN OTC DRUG LABEL
Packager Premium Distribution, LLC
Generic Name
Product Class Arteriolar Vasodilator
Product Number
Application Number ANDA076239
  • 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.  5% minoxidil topical solution 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, inflammed, infected, irritated, or painful
    • you use other medicines on the scalp
  • ASK DOCTOR

    ​Ask a doctor before use if you have heart disease

  • When using this product

    • do not apply on other part of the body
    • avoid contact with the eyes.  In case of accidental contact, rinse eyes with large amounts of cool tap water.
    • some individuals (people) have experienced changes in hair color and/or texture
    • it takes time to regrow hair.  Results may occur at 2 months with 2 times daily usage of this product.  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
    • you get unwanted facial hair growth
    • you do not see hair regrowth in 4 months
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    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 booklet.
    • 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 5% minoxidil topical solutions for men.
    • In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth that 2% minoxidil topical solution.
    • store at controlled room temperature 20° to 25° C (68° to 77° F)
  • Inactive ingredients

    Alcohol, Propylene Glycol, Purified Water

  • Questions or comments?

    Call your health professional or Follinique at 888-508-0320 Monday - Friday 9:00 AM - 5:00 PM (MST)

  • PRINCIPAL DISPLAY PANEL

    Regen by Follinique

    Men's 5% Minoxidil Topical Solution, USP

    Extra Strength For Men

    Hair Regrowth Treatment

    Reactivates hair follicles to stimulate regrowth

    Clinically proven to help regrow hair

    Unscented Topical Solution

    Not for use by women

    One 60 mL (2 fl oz) Bottle / One month supply

    regen

  • INGREDIENTS AND APPEARANCE
    REGEN 
    5% minoxidil topical solution solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70788-580
    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:70788-580-011 in 1 CARTON12/01/2016
    160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07623912/01/2016
    Labeler - Premium Distribution, LLC (079805390)

Related Drugs