{"effective_time":"20100716","id":"a064adb5-917c-4b94-a851-dac483f969ab","openfda":{},"package_label_principal_display_panel":["pictures U carton U carton U Carton U Carton Label"],"set_id":"12a3b145-225f-4f81-9c3f-ca2d3c57eae5","spl_product_data_elements":["Vitadil-5A Minoxidil Minoxidil Minoxidil"],"spl_unclassified_section":["Save leaflet for future reference • Provides more hair regrowth than Minoxidil Topical Solution 2%. • 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. Please read this leaflet carefully. It will help you understand how to use Vitadil-5A Extra Strength for Men and what to expect from its use. If you have any questions after reading this Ieaflet, or anytime while using Vitadil-5A Extra Strength for Men, you should ask your health care professional or contact GR Hair Solutions LLC at 1-800-203-2719. What is Vitadil-5A Extra Strength for Men? Vitadil-5A Extra Strength for Men is a pale yellow liquid medication containing 5% minoxidil for use only on the scalp to help regrow hair in men. Who may use Vitadil-5A Extra Strength for Men? Vitadil-5A Extra Strength for Men is for use only by men. Vitadil-5A 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. 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. Vitadil-5A Extra Strength for Men is for men with hair loss or thinning hair that begins on the vertex of the scalp. Vitadil-5A Extra Strength for Men is more likely to regrow hair in men with hair loss in the range shown. If men have more hair loss than shown, Vitadil-5A Extra Strength for Men may not work.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 Vitadil-5A Extra Strength for Men? Women should not use Vitadil-5A Extra Strength for Men because studies have shown it works no better in Women than Minoxidil Topical Solution for \\/Vomen. Some women may also grow facial hair. In addition, Vitadil-5A Extra Strength for Men may be harmful if used during pregnancy or breast-feeding. Vitadil-5A Extra Strength for Men should not be used on babies or for children under 18 years old. Vitadil-5A Extra Strength for Men 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, Vitadil-5A Extra Strength for Men 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. Vitadil-5A Extra Strength for Men differs from Minoxidil Topical Solution 2% (Regular Strength) for Men products in the following ways: • Contains 5% minoxidil (regular strength contains 2%) • reg rows more hair • With Vitadil-5A Extra Strength for Men, 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 Vitadil-5A Extra Strength for Men work for me? The amount of hair regrowth is different for each person. Not everyone will respond to Vitadil-5A Extra Strength for Men. The response to Vitadil-5A Extra Strength for Men cannot be predicted. It is unlikely anyone will be able to grow back all their hair. However, to see your best results with Vitadil-5A Extra Strength for Men make sure you get the medicine directly to the scalp and apply it twice a day, every day. 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 Vitadil-5A Extra Strength for Men may not work. How soon can I expect results from using Vitadil-5A Extra Strength for Men? Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with Vitadil-5A Extra Strength for Men 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 Vitadil-5A Extra Strength for Men. When you first begin to use Vitadil-5A Extra Strength for Men, 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 Vitadil-5A Extra Strength for Men reg rows hair. Remember, this increased hair loss is temporary. However, if it continues after two weeks, see your doctor. If Vitadil-5A Extra Strength for Men 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 Vitadil-5A Extra Strength for Men? If you experience hair regrowth, continued use of Vitadil-5A Extra Strength for Men is necessary or the hair loss will begin again. In studies with Minoxidil Topical Solution 5% (Extra Strength), hair regrowth has not been shown to last longer than 48 weeks of continuous treatment in large clinical trials. What happens if I completely stop using Vitadil-5A Extra Strength for Men? Willi keep the new hair? Continuous use of Vitadil-5A Extra Strength for Men is needed to maintain hair regrowth. If you stop using Vitadil-5A Extra Strength for Men, you will lose your newly regrown hair in 3 or 4 months. How do I use Vitadil-5A Extra Strength for Men? 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. It is not necessary to use fingertips when applying Vitadil-5A Extra Strength for Men. However, if you do use your fingertips, wash your hands well immediately afterwards. Allow time for Vitadil-5A Extra Strength for Men to dry completely before wearing a hat, or lying on a pillow, etc. Vitadil-5A Extra Strength for Men may cause staining of clothing or linens if damp on the scal p. When applying Vitadil-5A Extra Strength for Men 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 Vitadil-5A Extra Strength for Men? Apply Vitadil-5A Extra Strength for Men 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 Vitadil-5A Extra Strength for Men? If you miss one or two daily doses of Vitadil-5A Extra Strength for Men, just continue with your next dose. You should not make up for missed doses. Can I use Vitadil-5A Extra Strength for Men more than twice a day? Will it work faster, better? No. Vitadil-5A Extra Strength for Men 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 Vitadil-5A Extra Strength for Men 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 Vitadil-5A Extra Strength for Men? If you wash your scalp before applying Vitadil-5A Extra Strength for Men, use a mild shampoo. Can I use hair sprays, mousses, conditioners, gel, etc.? Yes. Hair sprays, spritz, or styling aids may be used on your hair while using Vitadil-5A Extra Strength for Men. For best results, Vitadil-5A Extra Strength for Men should be allowed to soak into the scalp before using any styling products. Try to develop a good routine of applying Vitadil-5A Extra Strength for Men 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 Vitadil-5A Extra Strength for Men? Yes. We have no evidence that coloring or perming your hair or that the use of relaxers change the effect of Vitadil-5A Extra Strength. 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 Vitadil-5A Extra Strength for Men has been washed off the hair and scalp before using color or perm chemicals. 2) For best results, do not apply Vitadil-5A Extra Strength for Men on the same day that you use a chemical treatment on your hair. 3) Do not use Vitadil-5A Extra Strength for Men 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 Vitadil-5A Extra Strength for Men as usual. 4) Simply restart your normal Vitadil-5A Extra Strength for Men routine. There is no need to use more Vitadil-5A Extra Strength for Men to make up for missed applications. Missing one day of Vitadil-5A Extra Strength will not affect your hair regrowth results. Can I apply Vitadil-5A Extra Strength for Men and wash my hair an hour later? No. For Vitadil-5A 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 hairstyles or hair loss because it allows for easy application through the hair and directly onto the scalp. Important: When applying Vitadil-5A 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 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 diagrams included in this leaflet or your hair loss is on the front of the scalp. Vitadil-5A 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 apply to babies and children. • Your 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 resu Its. • 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 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 during pregnancy 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 Vitadil-5A 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. Vitadil-5A Extra Strength for Men contains alcohol, which will cause burning or irritation of the eyes. If Vitadil-5A Extra Strength for Men accidentally gets into eyes, rinse with large amounts of cool tap water. Can Vitadil-5A Extra Strength for Men produce 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 Vitadil-5A Extra Strength for Men. Over time, the unwanted hair, if caused by Vitadil-5A 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 Vitadil-5A Extra Strength only to the scalp; 2) if you use your hands to apply Vitadil-5A Extra Strength, wash your hands well immediately afterwards; and 3) after your nighttime application of Vitadil-5A Extra Strength, allow enough drying time before going to bed (usually 2 to 4 hours) Can I use Vitadil-5A Extra Strength for Men for baldness or hair loss in babies or children? No. Vitadil-5A Extra Strength 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 call GR Hair Solutions LLC at 1-800-203-2719. Store at controlled room temperature 20° to 25°C (68° to 77° F). Distributed by: GR Hair Solutions LLC Palm Desert, CA 92260 800-203-2719"],"version":"3"}