Label: PANTENE PRO-V EXPERT COLLECTION HAIR REGROWTH TREATMENT FOR WOMEN- minoxidil liquid

  • NDC Code(s): 37000-798-60
  • Packager: Procter & Gamble Manufacturing Co.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Minoxidil 2% w/v

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  • Purpose

    Hair regrowth treatment

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  • Use

    to regrow hair on the scalp

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  • Warnings

    For external use only

    Flammable: Keep away from fire or flame

    Do not use if

    • 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 childbirth
    • 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. You may need to use this product 2 times a day 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 everyone.

    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)

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  • Directions

    • apply one mL with dropper 2 times a day directly onto 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
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  • 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.
    • 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 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.
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  • Inactive ingredients

    alcohol, propylene glycol, purified water

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  • Questions or comments?

    call toll-free: 1-800-719-9260

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  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE
    CINCINNATI, OH 45202

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  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

    CLINICALLY
    PROVEN TO HELP
    REGROW HAIR

    PANTENE
    PRO-V
    EXPERT

    COLLECTION

    Minoxidil
    TOPICAL SOLUTION USP, 2%

    Hair Regrowth
    Treatment for
    Women

    Unscented
    Revitalizes Hair Follicles

    1 MONTH SUPPLY

    1-60 mL (2 FL OZ) bottle

    APPROVED
    FDA

    Principal Display Panel - 60 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    PANTENE PRO-V EXPERT COLLECTION   HAIR REGROWTH TREATMENT FOR WOMEN
    minoxidil liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37000-798
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Minoxidil (Minoxidil) Minoxidil 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    alcohol  
    propylene glycol  
    water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-798-60 1 in 1 CARTON
    1 60 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075357 11/15/2013
    Labeler - Procter & Gamble Manufacturing Co. (004238200)
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