SPL UNCLASSIFIED SECTION.

Consumer Information. IMPORTANT INFORMATION ABOUTMinoxidil Topical Solution USP 2%Hair Regrowth TreatmentUNSCENTEDFor WomenOver 30 million American women experience hair thinning or hair loss, so youre not alone. Minoxidil topical solution 2% contains the only ingredient that is medically proven effective to help regrow hair in women.oClinically Proven to Help Regrow HairoReactivates Hair Follicles To Stimulate RegrowthoPreviously Available Only by PrescriptionSAVE THIS LEAFLET FOR FUTURE REFERENCEPlease read this leaflet carefully. It will help you understand how to use minoxidil topical solution 2% and what to expect from its use. If you have any questions after reading this leaflet, or anytime while using minoxidil topical solution 2%, you should ask your health care professional or call us at 1-800-719-9260.What is minoxidil topical solution 2%Minoxidil topical solution 2% is colorless liquid medication for use only on the top of the scalp to help regrow hair.Who may use minoxidil topical solution 2%Minoxidil topical solution 2% 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 2% is for general thinning of hair on the top of the scalp as shown below. Minoxidil topical solution 2% 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 2% 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. Who should NOT use minoxidil topical solution 2%Minoxidil topical solution 2% 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 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 2% will not improve hair loss due to:odamage from the use of hair care products which cause scarring or deep burns of the scalp.ohair grooming methods such as cornrowing or ponytails which require pulling the hair tightly back from the scalp. Do not use minoxidil topical solution 2% if hair loss is patchy as shown below.You should ask your doctor if you are unsure of the cause of your hair loss.Will minoxidil topical solution 2% work for meThe amount of hair regrowth is different for each person. Not everyone will respond to minoxidil topical solution 2%. The response to minoxidil topical solution 2% cannot be predicted. No one will be able to grow back all their hair.In clinical studies of mostly white woman aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported:FEMALE RESPONSE TO MINOXIDIL TOPICAL SOLUTION 2%Percent reporting hair growth19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 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 months (7% had moderate regrowth; 33% had minimal regrowth).What Minimal, Moderate and Dense Hair Regrowth Will Mean For YouNumber of HairsHair Density MinimalSome new hairs are seen, but not enough to cover thinning areas.Hairs in thinning areas do not grow as closely together as hairs on the rest of the head. ModerateNew hairs cover some or all of thinning areas.Hairs in the thinning areas grow more closely together, but are not as close together as hairs on the rest of the head. DenseNew hairs cover, or almost completely cover, thinning areas.Hairs in thinning areas grow as closely together as hairs on the rest of head.Can minoxidil topical solution 2% be used to prevent hair lossWe do not know if minoxidil topical solution 2% will prevent hair loss.How soon can expect results from using minoxidil topical solution 2%Since normal hair usually grows only 1/2 to inch per month, hair regrowth with minoxidil topical solution 2% also takes time. Generally new hair growth is slow for minoxidil topical solution 2% user. Continued use of times day for at least months is usually needed before you notice hair regrowth.If you do not see hair regrowth in months, stop using minoxidil topical solution 2% and see your doctor.When you first begin to use minoxidil topical solution 2%, your hair loss may continue for up to weeks. This hair loss is temporary. If you continue to lose hair after two weeks, see your doctor.If minoxidil topical solution 2% is working, what will the hair look likeAt 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 need to use minoxidil topical solution 2%If you respond to minoxidil topical solution 2%, you will need to use it times day to keep and continue the hair regrowth. Up to months of usage may be needed to see your best results from minoxidil topical solution 2%.What happens if completely stop using minoxidil topical solution 2% Will keep the new hairContinuous use of minoxidil topical solution 2% is needed to maintain hair regrowth. If you stop using minoxidil topical solution 2%, 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 2%You should apply dose (1 mL) of minoxidil topical solution 2% directly onto the scalp in the hair loss area TWO TIMES 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 miss dose or forget to use minoxidil topical solution 2%If you miss one or two daily doses of minoxidil topical solution 2%, just continue with your next dose. You should not make up for missed doses.Can use minoxidil topical solution 2% more than two times day Will it work faster, betterNo. Minoxidil topical solution 2% will not work faster or better if used more than two times day. Studies have been carefully conducted to determine the correct amount of minoxidil topical solution 2% 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 2%The most common side effects are itching and other skin irritations of the treated area of the scalp. Minoxidil topical solution 2% contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas. If minoxidil topical solution 2% accidentally gets into these areas, rinse with large amounts of cool tap water. Contact your doctor if irritation persists.What kind of shampoo should use with minoxidil topical solution 2%If you wash your scalp before applying minoxidil topical solution 2%, use mild shampoo.Can use hair sprays, mousses, conditioners, gels, etc.Yes. There is no need to change your usual hair care routine when using minoxidil topical solution 2%. However, you should apply minoxidil topical solution 2% first and wait for it to dry before applying your styling aids.Can have my hair colored or permed or use hair relaxers while using minoxidil topical solution 2%Yes. We have no information that these treatments change the effect of minoxidil topical solution 2%. However, to avoid possible scalp irritation, you should make sure all of the minoxidil topical solution 2% has been washed off the hair and scalp before using these chemicals.Can apply minoxidil topical solution 2% and wash my hair an hour laterNo. For minoxidil topical solution 2% to work best, you should allow minoxidil topical solution 2% to remain on the scalp for about hours before washing.Can go swimming or out in the rainYes. Avoid washing off the minoxidil topical solution 2%. If possible, apply minoxidil topical solution 2% to dry scalp after swimming, or wait about hours after application before going swimming. Do not let your scalp get wet from the rain after applying minoxidil topical solution 2%.Can minoxidil topical solution 2% produce unwanted hairAlthough 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 2% to areas other than the scalp, or by absorption into the circulatory system of low levels of the active ingredient, or by medical condition not related to the use of minoxidil topical solution 2%.If you experience unwanted hair, discontinue using minoxidil topical solution 2% and see your doctor for recommendations about appropriate treatment. After stopping use of minoxidil topical solution 2%, the unwanted hair, if caused by the use of minoxidil topical solution 2%, should go away over time.You can take steps to decrease the chances for unwanted hair growth:1) limit the application of minoxidil topical solution 2% only to the scalp, 2) if you use your hands to apply minoxidil topical solution 2%, wash your hands thoroughly afterwards, and 3) allow sufficient drying time (usually to hours before going to bed) after your nighttime application of minoxidil topical solution 2%.Can use minoxidil topical solution 2% for baldness or hair loss in babies and childrenNo. Minoxidil topical solution 2% 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 2%For external use onlyFlammable: Keep away from fire or flameDo not use ifoyour degree of hair loss is more than that shown on the other side of this leaflet, because this product may not work for youoyou have no family history of hair lossoyour hair loss is sudden and/or patchyoyour hair loss is associated with childbirthoyou do not know the reason for your hair lossoyou are under 18 years of age. Do not use on babies and children.oyour scalp is red, inflamed, infected, irritated, or painfuloyou use other medicines on the scalpAsk doctor before use if you have heart disease.When using this productodo not apply on other parts of the bodyoavoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.osome people have experienced changes in hair color and/or textureoit takes time to regrow hair. You may need to use this product times day for at least months before you see results.othe amount of hair regrowth is different for each person. This product will not work for everyone.Stop use and ask doctor ifochest pain, rapid heartbeat, faintness, or dizziness occurs oscalp irritation or redness occursosudden, unexplained weight gain occurs ounwanted facial hair growth occursoyour hands or feet swell oyou do not see hair regrowth in monthsMay be harmful if used when pregnant or breast-feeding.Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away. (1-800-222-1222)What factors may increase the risk of serious side effects with minoxidil topical solution 2%Minoxidil topical solution 2% should be applied only to the scalp. The risk of side effects may be greater when it is applied to other parts of the body.Directions for Use1) 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 applicator and apply one mL times 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 mild shampoo if you wash your scalp before applying minoxidil topical solution 2%.Using the Dropper Applicator1) Squeeze the rubber bulb and insert the dropper into the bottle. Release the bulb, allowing the dropper to fill to the mL line. If the level of the solution is above the 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 gradually release the solution. To prevent the solution from running off the scalp, apply small amount at 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 or call us at 1-800-719-9260.Store at 20o to 25oC (68o to 77oF).Keep tightly closed.Save this leaflet for future reference.Made in IsraelManufactured By PerrigoYeruham 80500, IsraelRev 03-14: 20200 00 J3. oClinically Proven to Help Regrow Hair. oReactivates Hair Follicles To Stimulate Regrowth. oPreviously Available Only by Prescription. odamage from the use of hair care products which cause scarring or deep burns of the scalp.. ohair grooming methods such as cornrowing or ponytails which require pulling the hair tightly back from the scalp.. Do not use minoxidil topical solution 2% if hair loss is patchy as shown below.. Minimal. Moderate. Dense. oyour degree of hair loss is more than that shown on the other side of this leaflet, because this product may not work for you. oyou have no family history of hair loss. oyour hair loss is sudden and/or patchy. oyour hair loss is associated with childbirth. oyou do not know the reason for your hair loss. oyou are under 18 years of age. Do not use on babies and children.. oyour scalp is red, inflamed, infected, irritated, or painful. oyou use other medicines on the scalp. odo not apply on other parts of the body. oavoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.. osome people have experienced changes in hair color and/or texture. oit takes time to regrow hair. You may need to use this product times day for at least months before you see results.. othe amount of hair regrowth is different for each person. This product will not work for everyone.. ochest pain, rapid heartbeat, faintness, or dizziness occurs oscalp irritation or redness occurs. osudden, unexplained weight gain occurs ounwanted facial hair growth occurs. oyour hands or feet swell oyou do not see hair regrowth in months. hair loss image. Chart. bottle image. Perrigo Logo.jpg.