Label: MINOXIDIL FOR WOMEN - minoxidil solution

  • 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 03/12

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

  • 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

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  • DO NOT USE IF

    • your degree of hair loss is more 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
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  • ASK A DOCTOR BEFORE USE IF YOU HAVE

    Heart disease

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  • 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.
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  • STOP USE AND ASK A DOCTOR IF

    • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
    • 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
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  • PREGNANCY OR BREAST-FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

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  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • DIRECTIONS

    • part your hair and apply with dropper one mL 2 times a day directly onto the scalp in the area of hair thinning/loss
    • spread the liquid evenly over the hair loss area. If you use your fingers, wash hands with soap and warm water immediately.
    • 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 this 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 controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.
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  • INACTIVE INGREDIENTS

    Alcohol (60% v/v), propylene glycol, purified water

    This Package Contains:

    • One 60 mL (2 FL OZ) bottle of Minoxidil Topical Solution (one month supply).
    • One child-resistant dropper applicator
    • Information leaflet on how to use and obtain best results

    Using the Dropper Applicator:

    1. Remove cap by pushing and turning in direction of the arrows on the cap
    2. Squeeze the rubber bulb and insert the dropper into the bottle. Release the bulb, allowing the dropper to fill to the 1 mL line. If the level of the solution is above the 1 mL line, squeeze the extra amount back into the bottle.
    3. Place the tip near the part of the scalp you want to treat and gently squeeze the bulb to gradually release the solution. To prevent the solution from running off the scalp, apply a small amount at a time.
    4. After each use attach the dropper to the bottle to make it child-resistant by turning it clockwise until tightly closed.

    Minoxidil Topical Solution is for women who have a general thinning of hair on the top of the scalp as shown.  Minoxidil Topical Solution has been shown to regrow hair in women with the following degrees of thinning hair or hair loss.

    7bad3e08-figure-01

    GRADUAL HAIR LOSS

    If women have more hair loss than shown above, Minoxidil Topical Solution may not work.

    Do not use if you have patchy hair loss as shown below.

    7bad3e08-figure-02

    DO NOT USE

    *This product is not manufactured or distributed by Pfizer Inc.distributors of Rogaine®.

    2004361 00660108F1 VC107716

    Distributed by:

    CVS Pharmacy, Inc.

    Woonsocket, RI 02895

    ©2008 CVS/pharmacy

    Made in Canada

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Original Formula

    Unscented

    CVS

    pharmacy

    Women’s hair regrowth treatment

    2% Minoxidil topical solution

    Clinically proven to help regrow hair

    Revitalizes hair follicles

    Unscented

    Compare to the active ingredient in Women’s Rogaine®*

    One Month Supply

    1-60 mL (2 FL OZ) Bottle

    7bad3e08-figure-03
    7bad3e08-figure-04

    ONE MONTH SUPPLY CARTON LABEL

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  • CONSUMER INFORMATION

    MINOXIDIL TOPICAL SOLUTION USP 2%

    Important information about – Minoxidil Topical Solution USP 2% for Women

    Save leaflet for future reference.

    • Hair regrowth treatment

    Over 30 million American women experience hair thinning or hair loss, so you’re not alone. Minoxidil Topical Solution contains the only ingredient that is medically proven effective to help regrow hair in women.

    Please read this leaflet carefully. It will help you understand how to use Minoxidil Topical Solution and what to expect from its use. If you have any questions after reading this leaflet, or anytime while using Minoxidil Topical Solution, you should ask your health care professional.

    What is Minoxidil Topical Solution?

    Minoxidil Topical Solution is a clear to pale yellow liquid medication for use only on the top of the scalp to help regrow hair.

    Who may use Minoxidil Topical Solution?

    Minoxidil Topical Solution may be appropriate for you if you are an adult who is at least 18 years old and experiencing gradually thinning hair or gradual hair loss on the top of the head. The common hereditary thinning or hair loss process begins slowly and may become noticeable only after years of gradual loss.

    Minoxidil Topical Solution is for general thinning of hair on the top of the scalp as shown below. Minoxidil Topical Solution has been shown to regrow hair in women with the degrees of hair loss shown. If women have more hair loss than shown, minoxidil topical solution may not work.

    Many of those experiencing hair loss have other family members with gradual thinning hair or hair loss. If there is no family history of gradual thinning or gradual hair loss, or hair loss is patchy, talk to your doctor.

    7bad3e08-figure-05

    GRADUAL HAIR LOSS

    Who should NOT use Minoxidil Topical Solution?

    Minoxidil Topical Solution will not prevent or improve hair loss related to pregnancy, the use of some prescription and non-prescription medications, certain severe nutritional problems (very low body iron; excessive vitamin A intake), the recently discontinued use of birth  control pills, low  thyroid states (hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp.  Also, Minoxidil Topical Solution will not improve hair loss due to:

    • damage from the use of hair care products which cause scarring or deep burns of the scalp.
    • hair grooming methods such as cornrowing or ponytails which require pulling the hair tightly back from the scalp.

    Do not use Minoxidil Topical Solution if hair loss is patchy as shown below.

    7bad3e08-figure-06

    DO NOT USE

    You should ask your doctor if you are unsure of the cause for your hair loss.

    Will Minoxidil Topical Solution work for me?

    The amount of hair regrowth is different for each person. Not everyone will respond to Minoxidil Topical Solution. The response to Minoxidil Topical Solution cannot be predicted. No one will be able to grow back all their hair.

    In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response of Minoxidil Topical Solution was reported:

    7bad3e08-figure-07
    7bad3e08-figure-08

    CLINICAL STUDY TABLE

    Can Minoxidil Topical Solution be used to prevent hair loss?

    We do not know if Minoxidil Topical Solution will prevent hair loss.

    How soon can I expect results from using Minoxidil Topical Solution?

    Since normal hair usually grows only ½ to 1 inch per month, hair regrowth with Minoxidil Topical Solution also takes time.  Generally new hair growth is slow for a Minoxidil Topical Solution user.  Continued use of 2 times a day for at least 4 months is usually needed before you notice hair regrowth.

    If you do not see hair regrowth in 4 months, stop using Minoxidil Topical Solution and see your doctor.

    When you first begin to use Minoxidil Topical Solution, your hair loss may continue for up to 2 weeks.  This hair loss is temporary.  If you continue to lose hair after two weeks, see your doctor.

    If Minoxidil Topical Solution is working, what will the hair look like?

    At first, hair growth may be soft, downy, colorless hairs. After further use, the new hairs should be the same color and thickness as the other hairs on your scalp.

    How long do I need to use Minoxidil Topical Solution?

    If you respond to Minoxidil Topical Solution, you will need to use it 2 times a day to keep and continue the hair regrowth. Up to 8 months of usage may be needed to see your best results from Minoxidil Topical Solution.

    What happens if I completely stop using Minoxidil Topical Solution? Will I keep the new hair?

    Continuous use of Minoxidil Topical Solution is needed to maintain hair regrowth.  If you stop using Minoxidil Topical Solution, the normal hair loss process will start again.  You will probably lose your newly regrown hair in three to four months.

    What is the dosage of Minoxidil Topical Solution?

    You should apply a dose (1 mL) of Minoxidil Topical Solution directly onto the scalp in the hair loss area TWO TIMES A DAY; for example, once in the morning and once at night. Each bottle should last about one month, if used as directed. Please refer to the “Directions for Use” section of this leaflet.

    What if I miss a dose or forget to use Minoxidil Topical Solution?

    If you miss one or two daily doses of Minoxidil Topical Solution, just continue with your next dose. You should not make up for missed doses.

    Can I use Minoxidil Topical Solution more than two times a day?

    Will it work faster, better?

    No.  Minoxidil Topical Solution will not work faster or better if used more than 2 times a day. Studies have been carefully conducted to determine the correct amount of Minoxidil Topical Solution needed to get the best results. More frequent use or larger doses have not been shown to speed up hair growth and may increase your chances of side effects.

    What are the most common side effects with Minoxidil Topical Solution?

    The most common side effects are itching and other skin irritations of the treated area of the scalp.

    Minoxidil Topical Solution contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas.  If Minoxidil Topical Solution accidentally gets into these areas, rinse with large amounts of cool tap water.  Contact your doctor if irritation persists.

    What kind of shampoo should I use with Minoxidil Topical Solution?

    If you wash your scalp before applying Minoxidil Topical Solution, use a mild shampoo.

    Can I use hair sprays, mousses, conditioners, gels, etc.?

    Yes.  There is no reason to change your usual hair care routine when using Minoxidil Topical Solution. However, you should apply Minoxidil Topical Solution first and wait for it to dry before applying your styling aids.

    Can I have my hair colored or permed or use hair relaxers while using Minoxidil Topical Solution?

    Yes.  We have no information that these treatments change the effect of Minoxidil Topical Solution. However, to avoid possible scalp irritation, you should make sure all of the Minoxidil Topical Solution has been washed off the hair and scalp before using these chemicals.

    Can I apply Minoxidil Topical Solution and wash my hair an hour later?

    No.  For Minoxidil Topical Solution to work best, you should allow Minoxidil Topical Solution to remain on the scalp for about 4 hours before washing.

    Can I go swimming or out in the rain?

    Yes.  Avoid washing off the Minoxidil Topical Solution.  If possible, apply Minoxidil Topical Solution to a dry scalp after swimming, or wait about 4 hours after application before going swimming.  Do not let your scalp get wet from the rain after applying Minoxidil Topical Solution.

    Can Minoxidil Topical Solution produce unwanted hair?

    Although unwanted hair growth has been reported on the face and on other parts of the body, such reports have been infrequent.  The unwanted hair growth may be caused by the transfer of Minoxidil Topical Solution  to areas other than the scalp, or by absorption into the circulatory system of low levels of the active ingredient, or by a medical condition not related to the use of Minoxidil Topical Solution.

    If you experience unwanted hair, discontinue using Minoxidil Topical Solution and see your doctor for recommendations about appropriate treatment.  After stopping use of Minoxidil Topical Solution, the unwanted hair, if caused by the use of Minoxidil Topical Solution, should go away over time.

    You can take steps to decrease the chances of unwanted hair growth: 1) limit the application of Minoxidil Topical Solution only to the scalp; 2) if you use your hands to apply Minoxidil Topical Solution, wash your hands thoroughly afterwards; and 3) allow sufficient drying time (usually 2 to 4 hours before going to bed) after your nighttime application of Minoxidil Topical Solution.

    Can I use Minoxidil Topical Solution for baldness or hair loss in babies and children?

    No. Minoxidil Topical Solution must not be used to treat baldness or hair loss in babies or children.

    Are there any special warnings about the use of Minoxidil Topical Solution?

    For external use only

    Flammable: Keep away from fire or flame

    Do not use if

    • your degree of hair loss is more than that shown on the front of this leaflet, 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

    If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    What factors may increase the risk of serious side effects with Minoxidil Topical Solution?

    Minoxidil Topical Solution should be applied only to the scalp.  The risk of side effects may be greater when Minoxidil Topical Solution is applied to other parts of the body.

    Directions for Use

    1. Remove the cap. To remove, push down and turn in direction of the arrows on the cap.
    2. Part your hair in the area of hair thinning/loss. Follow the instructions below for using the dropper and apply one mL 2 times a day directly onto the scalp in the hair loss area. Do not use more. Spread the liquid evenly over the hair loss area. If you use your fingers, wash hands with soap and water immediately. Each bottle should last about one month, if used as directed. Use a mild shampoo if you wash your scalp before applying Minoxidil Topical Solution.

    Using the Dropper Applicator

    I:\Regulatory Affairs\Labeling\OTC\OTC Regulatory\_Drug Listing\Minoxidil 5%\bottle.jpg
    1. Squeeze the rubber bulb and insert the dropper into the bottle. Release the bulb, allowing the dropper to fill to the 1 mL line. If the level of the solution is above the 1 mL line, squeeze the extra amount back into the bottle.
    2. Next, place the tip near the part of the scalp you want to treat and gently squeeze the bulb to gradually release the solution. To prevent the solution from running off the scalp, apply a small amount at a time.
    3. After each use attach the dropper to the bottle to make it child-resistant by turning it clockwise until tightly closed.

    If you have any other questions, ask your health care professional.

    Store at Controlled Room Temperature 20º to 25ºC (68º to 77ºF). Keep tightly closed.

    Save this leaflet for future reference.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Manufactured by: Contract Pharmaceuticals Ltd.

    7600 Danbro Crescent

    Mississauga, ON

    Canada, L5N 6L6

    For: Actavis Mid Atlantic LLC

    1877 Kawai Road

    Lincolnton, NC 28092 USA

    FORM NO. 0066-2 Rev. 1/09

    2004688 VC3272

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  • INGREDIENTS AND APPEARANCE
    MINOXIDIL FOR WOMEN 
    minoxidil solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-066
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MINOXIDIL (MINOXIDIL) MINOXIDIL 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL  
    PROPYLENE GLYCOL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-066-72 1 in 1 CARTON
    1 60 mL in 1 BOTTLE
    2 NDC:59779-066-76 3 in 1 CARTON
    2 60 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074588 01/01/2003
    Labeler - CVS (062312574)
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