Label: MENS ROGAINE EXTRA STRENGTH UNSCENTED- minoxidil solution

  • NDC Code(s): 69968-0089-1, 69968-0089-3
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated September 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Minoxidil 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, 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

    • apply one mL with dropper 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 solution 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 than 2% minoxidil topical solution
    • store at controlled room temperature 20º to 25º C (68º to 77º F)
  • Inactive ingredients

    alcohol, propylene glycol, purified water

  • Questions?

    • call toll-free 800-764-2463 or 215-273-8755 (collect )
    • visit www.rogaine.com
  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

    #1 DERMATOLOGIST

    RECOMMENDED BRAND

    MEN'S

    Rogaine ®

    EXTRA STRENGTH

    5% Minoxidil

    Topical Solution

    Hair Regrowth Treatment

    REACTIVATES

    HAIR FOLLICLES

    TO STIMULATE REGROWTH

    Topical Solution

    CLINICALLY PROVEN TO

    HELP REGROW HAIR

    UNSCENTED

    Not For Use By Women

    One Month Supply. One 60 mL (2 fl oz) Bottle

    Rogaine_01

  • INGREDIENTS AND APPEARANCE
    MENS ROGAINE EXTRA STRENGTH UNSCENTED 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0089
    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:69968-0089-11 in 1 CARTON07/16/2010
    160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69968-0089-33 in 1 CARTON07/16/2010
    260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02083407/16/2010
    Labeler - Kenvue Brands LLC (118772437)
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