MINOXIDIL SOLUTION SOLUTION [NUTRASTIM HAIR LLC]

MINOXIDIL SOLUTION SOLUTION [NUTRASTIM HAIR LLC]
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NDC 71517-001-01, 71517-001-02
Set ID 53f66d84-c5b2-1a90-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Nutrastim Hair LLC
Generic Name
Product Class Arteriolar Vasodilator
Product Number
Application Number ANDA075598
  • PURPOSE

    To regrow hair on the scalp.

  • WARNINGS

    • For external use only.
    • For use by women only.
    • Flammable. Keep away from fire or flame.
  • DO NOT USE

    • Your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you.
    • You have no family history of hair loss.
    • Your hair loss is sudden and/or patchy.
    • Your hair loss is associated with child birth.
    • 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 DOCTOR

    Ask a doctor before use if you have heart disease

  • WHEN USING

    • 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 women, you may need to use this product for at least 4 months before you see results.
    • The amount of hair regrowth is different with each person. This product will not work for all women.
  • STOP USE

    • 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.
  • 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. (1-800-222-1222).

  • Directions

    • Apply 1 ml, 2 times daily directly with the dropper 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

    • Before use see hair loss pictures on side of this box.
    • Keep the box, it contains important information.
    • In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution was 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth: 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
    • Store at 20° to 25° C (68° to 77° F).

    Keep tightly closed.

  • INACTIVE INGREDIENT

    Alcohol, propylene glycol, purified water

  • QUESTIONS

    Call us at 1-844-892-8578

    Visit nutrastimhair.com

    for more information about hair thinning, visit

    nutrastimhair.com/women-education/

  • ACTIVE INGREDIENT

    Minoxidil 2% w/v

  • PRINCIPAL DISPLAY PANEL

    Minoxidil Label

  • INGREDIENTS AND APPEARANCE
    MINOXIDIL SOLUTION 
    minoxidil solution solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71517-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL20 g  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:71517-001-022 in 1 CARTON06/29/2017
    1NDC:71517-001-0160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07559806/29/2017
    Labeler - Nutrastim Hair LLC (080274282)

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