NIOXIN HAIR REGROWTH TREATMENT EXTRA STRENGTH FOR MEN (MINOXIDIL) SOLUTION [THE WELLA CORPORATION]

NIOXIN HAIR REGROWTH TREATMENT EXTRA STRENGTH FOR MEN (MINOXIDIL) SOLUTION [THE WELLA CORPORATION]
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NDC 69282-002-18, 69282-002-60
Set ID d7502392-864e-4038-bb19-8b1c90ccaa07
Category HUMAN OTC DRUG LABEL
Packager The Wella Corporation
Generic Name
Product Class Arteriolar Vasodilator
Product Number
Application Number ANDA075357
  • 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. 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. (1-800-222-1222)

  • 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 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% for men
    • in clinical studies with mostly white men aged 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 20° to 25°C (68° to 77°F). Keep tightly closed.
  • Inactive ingredients

    alcohol, propylene glycol, purified water

  • Questions?

    Call 1-800-719-9260

  • SPL UNCLASSIFIED SECTION

    MADE IN CANADA

    Dist. By THE WELLA CORPORATION,
    WOODLAND HILLS, CA 91367

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

    NIOXIN®

    MINOXIDIL
    TOPICAL SOLUTION USP 5%

    HAIR REGROWTH TREATMENT

    EXTRA STRENGTH FOR MEN

    Clinically Proven To Help Regrow Hair
    Reactivates Hair Follicles To Stimulate Regrowth

    NOT FOR USE BY WOMEN

    ONE MONTH SUPPLY
    FDA APPROVED

    1-60 mL (2 fl oz) Bottle
    UNSCENTED

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

  • INGREDIENTS AND APPEARANCE
    NIOXIN HAIR REGROWTH TREATMENT EXTRA STRENGTH FOR MEN 
    minoxidil solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69282-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69282-002-601 in 1 CARTON11/01/2014
    160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:69282-002-183 in 1 CARTON11/01/2014
    260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07559811/01/2014
    Labeler - The Wella Corporation (001399815)

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