Label: EXT EXTREME HAIR THERAPY - minoxidil solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 14, 2011

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts
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  • Active Ingredient

    Minoxidil 5.0% w/v Close
  • Purpose

    Hair regrowth treatment for men
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  • Use

    to regrow hair on the top of the scalp (vertex only, see pictures on side of the carton)
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  • Warnings

    For external use only
    Flammable:
    Keep away from fire or flame Close
  • 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 medications on the scalp.
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  • 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 waler.
    • 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.
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  • 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
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  • PREGNANCY OR BREAST FEEDING

    May be harmful if used during pregnancy or breast-feeding.
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  • 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. Close
  • Directions

    • apply one mL 2 times a day directly onto the scalp in the area of hairloss
    • using more or more often will not improve results
    • continued use is necessary 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 booklet
    • keep this 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%
    • in clinical studies with mostly while men aged 18-49 years with moderate degrees of hair loss, Minoxidil Topical Solution 5% provided more hair regrowth than Minoxidil Topical Solution 2%
    • store at room temperature between 200 to 250 C (680 to 770 F).
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  • Inactive Ingredient

    alcohol 30% v/v, propylene glycol 50% v/v, purified water Close
  • Questions and Comments?

    write to: GO-Labs, P.O. Box 278, Kannapolis, NC 28082-0278
    Close
  • Customer Information

    EXT Extreme Hair Therapy
    (Minoxidil Topical Solution 5%)
    Hair Regrowth Treatment
    Extra Strength for Men

    Save booklet for future reference.
    • Provides more hair regrowth than Minoxidil 1%
    • It takes time to regrow hair. Results may occur at  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.
    Please read this booklet carefully. It will help you understand how to use EXT Extra Strength for Men and what to expect from its use. If you have any questions after reading this booklet, or anytime while using EXT Extra Strength for Men, you should ask your health care professional or write to: Hair Club for Men and Women, 1515 S. Federal Hwy. Boca Raton, FL 33432, 800-261-5092.
    What is EXT Extra Strength for Men?
    EXT Extra Strength for Men is a colorless liquid medication containing 5% minoxidil for use only on the scalp to help regrow hair in men.
    Who may use EXT Extra Strength for Men?
    EXT Extra Strength for Men is for Lise only by men. EXT .Extra Strength for Men may be appropriate for you If you are a male at least 18 years old and experiencing gradually thinning hair or gradual hair loss on the top of the scalp (vertex only, as shown on the other side of this booklet). It is not intended for frontal baldness or a receding hairline. The common inherited thinning or hair loss process begins slowly and may become noticeable only after years of gradual loss.Minoxidil topical solution 5% is for men with hair loss or thinning hair that begins on the vertex of the
    scalp. Minoxidil topical solution 5% is more likely to regrow hair in men with hair loss in the range shown below. If men have more hair loss than shown, minoxidil topical solution 5% may not work.
    picture of hair loss
    Many of those experiencing hair loss have other family members with gradual thinning hair or hair loss. If you have no family history of gradual thinning hair or of gradual hair loss, or your hair loss is patchy, see your doctor.
    Who should NOT use minoxidil topical solution 5%?
    • Women should not use minoxidil topical solution 5% because studies have shown it works no better in women than minoxidil topical solution 2%. Some women may also grow facial hair. In addition, minoxidil topical solution 5% may be harmful if used during pregnancy or  breastfeeding.
    • Minoxidil topical solution 5% should not be used on babies or for children under 18 years old.
    • Minoxidil topical solution 5% will not prevent or improve hair loss which may occur with the use of some prescription and non-prescription medications, certain severe nutritional problems (very low body iron; too much vitamin A intake), low thyroid states (hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp. Also, minoxidil topical solution 5% 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 if you are not sure of the reason for your hair loss.
    Minoxidil topical solution 5% differs from the regular strength product in the following ways:
    • Contains 5% minoxidil (the regular strength contains 2%).
    • Regrows more hair.
    • With minoxidil topical solution 5%, 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.
    • Is more likely to cause scalp irritation. If scalp irritation continues or worsens, stop use and see a doctor. See Warnings on carton or bottle label.
    Will minoxidil topical solution 5% work for me?
    The amount of hair regrowth is different for each person. Not everyone will respond to minoxidil topical solution 5%. The response to minoxidil topical solution 5% cannot be predicted. It is unlikely anyone will be able to grow back all their hair. However, to see your best results with minoxidil topical solution 5%, make sure you get the medicine directly to the scalp and apply it twice a day, everyday. You may get better results if you have been losing your hair for a short period of time or have little hair loss. However, for some men minoxidil topical solution 5% may not work.
    How soon can I expect results from using minoxidil topical solution 5%?
    Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with minoxidil topical solution 5% also takes time. Results may be seen as early as 2 months with twice daily use. For some men, it may take at least 4 months for results to be seen. If you do not see any results after 4 months, stop using minoxidil topical solution 5%. When you first begin to use minoxidil topical solution 5%, your hair loss may increase temporarily for up to 2 weeks. This is likely a sign that you are getting rid of old hairs in order to regrow more new hairs. This temporary increase in hair loss is expected and is a part of the process for how minoxidil topical solution 5% regrows hair. Remember, this increased hair loss is temporary. However, if it continues after two weeks, see your doctor.
    If minoxidil topical solution 5% is working, what will the hair look like?
    At first, hair growth is usually soft, downy, colorless hairs (like peach fuzz). 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 5%?
    If you experience hair regrowth, continued use of minoxidil topical solution 5% is necessary or the hair loss will begin again. In studies with minoxidil topical solution 5%, hair regrowth has not been shown to last longer than 48 weeks of continuous treatment in large clinical trials.
    What happens if II completely stop using minoxidil topical solution 5%? Will I keep the new hair?
    Continuous use of minoxidil topical solution 5% is needed to maintain hair regrowth. If you stop using minoxidil topical solution 5%, you will lose your newly regrown hair in 3 to 4 months.
    How do I use minoxidil topical solution 5%?
    For best results, apply 1 mL with dropper 2 times a day directly onto the scalp in the hair loss area . Using more or using more often will not improve results. Each bottle should last one month, if used as directed. Allow time for minoxidil topical solution 5% to dry completely before wearing a hat, or lying on a pillow, etc. Minoxidil topical solution 5% may cause staining of clothing or linens if damp on the scalp. When applying minoxidil topical solution 5% at night, be sure to allow 2 to 4 hours to dry completely. Never take this product by mouth or apply to other parts of the body.
    When do I use minoxidil topical solution 5%?
    Apply minoxidil topical solution 5% once in the morning and once at night. The nighttime application should occur 2 to 4 hours before going to bed to allow for drying. Each bottle should last one month, if used as directed.
    What if I miss a dose or forget to use minoxidil topical solution 5%?
    If you miss one or two daily doses of minoxidil topical solution 5%, just continue with your next dose. You should not make up for missed doses.
    Can I use minoxidil topical solution 5% more than twice a day? Will it work faster, better?
    No. Minoxidil topical solution 5% will not work faster or better if used more than two times a day. Studies have been carefully conducted to determine the correct amount of minoxidil topical solution 5% 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 chance of side effects.
    What kind of shampoo should I use with minoxidil topical solution 5%?
    If you wash your scalp before applying minoxidil topical solution 5%, use a mild shampoo.
    Can I use hair sprays, mousses, conditioners, gels, etc.?
    Yes. Hair sprays, spritz, or styling aids may be used on your hair while using minoxidil topical solution 5%. For best results, minoxidil topical solution 5% should be allowed to soak into the scalp before using any styling products. Try to develop a good routine of applying minoxidil topical solution 5% first, and then applying styling products and style as usual. Keep in mind that your best results will be seen with proper application.
    Can I have my hair colored or permed or use hair relaxers while using minoxidil topical solution 5%?
    Yes. We have no evidence that coloring or perming your hair or that the use of relaxers change the effect of minoxidil topical solution 5%. However, because the use of a permanent wave and hair color can cause scalp irritation on certain people, we recommend the following precautions:
    1) To avoid possible scalp irritation, you should make sure all of the minoxidil topical solution 5% has been washed off the hair and scalp before using color or perm chemicals.
    2) For best results, do not apply minoxidil topical solution 5% on the same day that you use a chemical treatment on your hair.
    3) Do not use minoxidil topical solution 5% for 24  hours after using any chemicals to make sure your scalp has not been irritated by the perm or color treatment. If no irritation occurs, continue use of minoxidil topical solution 5% as usual.
    4)Simply restart your normal EXT Extra Strength for Men routine. There is no. need to use more EXT Extra Strength for Men to make up for the missed applications. Missing one day of EXT Extra Strength for Men will not affect your hair regrowth results.
    Can I apply EXT Extra Strength for Men and wash my hair an hour later?
    No. For EXT Extra Strength for Men to work best, you should allow it to stay on the scalp for about 4 hours before washing.
    Using the Dropper Applicator.
    The child-resistant dropper can be useful for a broad range of hair styles or hair loss because it allows for easy application through the hair and directly onto the scalp.
    Important: When applying EXT Extra Strength for Men, make sure the medicine comes in direct contact with the scalp.
    1) Squeeze the rubber bulb and put the dropper into the bottle. Release the bulb, allowing the dropper to fill to the 1 mL line. If the level of medicine is above the 1 mL line, squeeze the extra amount back into the bottle.
    2) Next, place the tip of the dropper near the part of the scalp you want to treat and gently squeeze the bulb to release the medicine gradually. To prevent the medicine from running off the scalp, apply a small amount at a time.
    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 other side of this booklet or your hair loss is on the front of the scalp. EXT Extra
    Strength for Men 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
    • scalp is red, inflamed, infected, irritated, or painful
    • you use other medications 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 and 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.

    What are the most common side effects with EXT Extra Strength for Men?
    The most common side effects are itching and skin irritation of the treated area of the scalp. If scalp irritation continues, stop use and see a doctor. EXT Extra Strength for Men contains alcohol, which will cause burnng or irritation of the eyes. If EXT Extra Strength for Men accidentally gets into eyes, rinse with large amounts of cool tap water.
    Can EXT Extra Strength for Men produced unwanted hair growth?
    Unwanted hair growth on the face and other parts of the body has been reported in women. But it is rare and reversible. If you develop unwanted hair, stop using EXT Extra Strength for Men. Over time, the unwanted hair, if caused by EXT EXtra Strength for Men, will go away. You can take the following steps to decrease the chances of unwanted hair growth:
    1) limit the application of EXT Extra Strength for Men only to the scalp;
    2) if you use your hands to apply EXT Extra Strength for Men, wash your hands well immediately afterwards; and
    3) after your nighttime application of EXT Extra Strength for Men, allow enough drying time before going to bed (usually 2 to 4 hours).
    Can I use EXT Extra Strength for Men for baldness or hair loss in babies or children?
    No. EXT Extra Strength for Men must not be used to treat baldness or hair loss in babies and children.
    If you have any other questions, ask your health care professional or write to: Hair Club for Men and Women, 1515 S. Federal Hwy., Boca Raton, FL 33432,800-261-5092.
    Store at controlled room temperature 20° to 25°C (68° to 77°F). Keep tightly closed.
    Manufactured by:
    GO Labs
    P.O. Box 278
    Kannapolis, NC 28081
    704-932-6195
    One 60 mL Bottle: NDC 67007-050-22
    Two 60 mL Bottles: NDC 67007~050-44
    9 HC EXT-5%-SIV03 June 2010
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  • INGREDIENTS AND APPEARANCE
    EXT EXTREME HAIR THERAPY 
    minoxidil solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52512-601
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Minoxidil (UNII: 5965120SH1) (Minoxidil - UNII:5965120SH1) Minoxidil 50 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Alcohol (UNII: 3K9958V90M)  
    Tert-Butyl Alcohol (UNII: MD83SFE959)  
    Denatonium Benzoate (UNII: 4YK5Z54AT2)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52512-601-60 88 in 1 CASE
    1 60 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA076239 08/26/2004
    Labeler - Ei Inc. (105803274)
    Registrant - Ei Inc. (105803274)
    Establishment
    Name Address ID/FEI Business Operations
    Ei Inc. 105803274 manufacture
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