INFORMATION ABOUT YOUR TREATMENT Indication OXISTAT Lotion is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Please see Important Safety Information inside and accompanying Brief Summary of full Prescribing Information.
Important Safety Information Do not use OXISTAT Lotion if you have hypersensitivity to any ingredient of this product. Use the product only externally. OXISTAT Lotion is not to be used in the eyes or vagina. Avoid contact with the eyes, nose, mouth, and other mucous membranes. Do not cover the treated area unless directed otherwise by your physician. Use the medication for the full treatment time recommended by your physician, even though symptoms may have improved. Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing. In clinical studies with OXISTAT, the most commonly reported side effects were burning and stinging; less commonly reported side effects were itching, scaling, tingling, pain, and blistering. If you are pregnant or nursing a baby, consult with your physician prior to using this product. For more information, consult your physician. Please see accompanying Brief Summary of full Prescribing Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 2
Table of Contents About Fungal Skin Infections...4 Are you at risk for fungal skin infections?....4 Where s the infection?......5 Ringworm (tinea corporis)...5 Jock itch (tinea cruris)...5 About Athlete s Foot... 6 Athlete s foot (tinea pedis)........ 6 How to know if you have it........ 6 Watch out for athlete s foot!........7 About OXISTAT Lotion...8 Possible side effects....8 Stay on treatment......8 Apply as directed.....9 Helpful Tips...10 5 healthy habits....10 Athlete s foot....11 Ringworm........11 Jock itch........11 3
About Fungal Skin Infections There are several common skin infections caused by one or more types of fungi (the plural form of fungus ). These infections are known by their medical name, tinea (TIN-ee-uh). Sometimes fungi are named for the place where they occur on the body. For example, tinea pedis means fungus of the foot. Are you at risk for fungal skin infections? Fungal skin infections are common. Here are 2 ways that these infections may develop and spread: 1. Conditions on your skin encourage fungi to grow and cause symptoms Fungi thrive when your skin is warm and moist. Sweating a lot and/or wearing tight-fitting clothing can allow fungi to grow, especially between the folds of the skin. 2. You catch a new fungal infection from someone or something else You can get a fungal skin infection through direct contact with people or animals who have a fungal skin infection. You can also get a fungal skin infection by coming in contact with contaminated objects such as shoes, clothing, hairbrushes, bed linens, towels, floors, carpets, floor mats, or similar objects. 4
Where s the infection? Fungal infections can occur just about anywhere on the skin. Ringworm (tinea corporis) Ringworm is a fungal skin infection affecting the body. It is called ringworm because the infection sometimes appears as a red, round or ring-shaped rash, but it is not caused by worms. Jock itch (tinea cruris) Jock itch is a fungal skin infection that affects the groin area, including the genitals and upper inner thighs. The name might make you think that only athletes get jock itch, but it can affect anyone. Jock itch can cause a red, itchy, burning rash. 5
About Athlete s Foot Athlete s foot (tinea pedis) Athlete s foot is a common foot infection caused by fungi. It can occur anywhere on the foot, but it often appears between the toes or on the bottom or sides of the feet. How to know if you might have it Athlete s foot appears as a scaly, cracked, blistered, and/or peeling rash. It often causes a stinging, itching, or burning sensation. 6
Watch out for athlete s foot! People increase their risk of developing athlete s foot by walking barefoot in damp, contaminated public areas such as locker rooms and showers. An infection can also spread from one part of the body to another. For example, athlete s foot may lead to jock itch if an affected part of the body, or a contaminated object such as a towel, comes in contact with an unaffected area. 7
About OXISTAT Lotion 8 Your doctor may prescribe OXISTAT Lotion to treat your fungal skin infection. OXISTAT Lotion is a medicine that can treat the fungi on the skin, when used as directed. Your doctor may choose OXISTAT Lotion because it Treats athlete s foot, ringworm, and jock itch Can be applied without you touching your toes (when the 30-mL bottle with the convenient interdigital applicator is prescribed) Can be used once or twice a day; use as prescribed by your doctor Possible side effects The most common side effects reported were burning and stinging. Contact your doctor if you have any side effects. Stay on treatment Continue to use OXISTAT Lotion for the entire time your doctor recommends, even when the infection appears to have healed, to help reduce the chance of the fungal skin infection coming back. Contact your doctor if there is no improvement after 2 to 4 weeks of treatment, or sooner if your condition worsens. Important Safety Information Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing. In clinical studies with OXISTAT, the most commonly reported side effects were burning and stinging; less commonly reported side effects were itching, scaling, tingling, pain, and blistering. Please see additional Important Safety Information throughout and accompanying Brief Summary of full Prescribing Information.
Apply as directed STEP 1: Wash your hands before and after using OXISTAT Lotion STEP 2: Clean and dry the affected area before using OXISTAT Lotion STEP 3: Apply OXISTAT Lotion to the affected area STEP 4: Continue to use OXISTAT Lotion for the amount of time indicated by your doctor You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 9
Helpful Tips There are at least 5 things you can do to avoid getting a fungal infection in the future. 5 healthy habits 1. Keep your skin clean and dry 2. Change clothes daily, and wash and dry them thoroughly before the next use 3. Do not share personal items: shoes, clothing, towels, etc 4. Use a body powder to help absorb moisture 5. Avoid infected animals, and treat pets that have skin diseases ALWAYS REMEMBER to keep your skin clean and dry 10
For the different types of fungal skin infections, there are other things you can do, as well. Athlete s foot Wash your feet every day and dry them completely Avoid walking barefoot in public areas, and wear flip-flops or water shoes in locker rooms, pools, and showers Wear clean socks and try to keep your feet dry Do not share footwear (shoes, sandals, sneakers, slippers, etc) with others Ringworm Keep your skin clean and dry Do not share towels Avoid infected animals (look for hair loss, mostly in patches) Jock itch Keep your groin area clean and dry Dry yourself completely after bathing, especially between the folds of the skin Wear clean, cotton underwear or loose-fitting pants; change your underwear at least once a day or more if you perspire a lot Do not share towels 11
OXISTAT Lotion: THE POWER YOU NEED WHEN YOU NEED IT MOST For more information about OXISTAT Lotion and how you can SAVE on treatment, please visit www.oxistatlotion.com. Indication OXISTAT Lotion is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see Important Safety Information inside and accompanying Brief Summary of full Prescribing Information. 100 College Road West, Princeton, NJ 08540. OXISTAT is a registered trademark of Fougera Pharmaceuticals Inc. 2017 Fougera Pharmaceuticals Inc. All rights reserved. P-OXI-1347314 08/2017
SUMMARY OF INFORMATION ABOUT OXISTAT (oxiconazole nitrate) Lotion, 1% The Risk information presented here is not comprehensive. To learn more, talk to your healthcare provider or pharmacist about OXISTAT Lotion. The FDA-approved product labeling can be found at www.oxistat.com. What is OXISTAT Lotion? OXISTAT Lotion is indicated for the topical treatment of the following infections of the skin: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Who should not use OXISTAT Lotion? Do not use OXISTAT Lotion if you are allergic (hypersensitive) to any ingredient in OXISTAT Lotion. OXISTAT Lotion is not for use in your eyes or vagina. What should I tell my healthcare provider before using OXISTAT Lotion? Before using OXISTAT Lotion, tell your healthcare provider about all your medical conditions, including if you: Are pregnant or plan to become pregnant. It is not known if OXISTAT Lotion can harm your unborn baby. Are breastfeeding or plan to breastfeed. OXISTAT Lotion passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use OXISTAT Lotion? Use OXISTAT Lotion exactly as your healthcare provider tells you to use it. OXISTAT Lotion should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Tinea corporis and tinea cruris should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence. The hands should be washed after applying the medication to the affected area(s). Use the medication for the full treatment time recommended by the physician, even though symptoms may have improved. Notify the physician if there is no improvement after 2 to 4 weeks, or sooner if the condition worsens (see below). Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing. What should I avoid while using OXISTAT Lotion? Avoid contact with the eyes, nose, mouth, and other mucous membranes. OXISTAT Lotion is for external use only. Avoid the use of occlusive dressings unless otherwise directed by the physician. Do not use this medication for any disorder other than that for which it was prescribed. What are the possible side effects of OXISTAT Lotion? The most commonly reported side effects in a clinical trial were burning and stinging, and less commonly reported itching, scaling, tingling, pain and blistering. These are not all of the possible side effects of OXISTAT Lotion. You may experience other side effects of OXISTAT Lotion that are not mentioned here. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. What other medications might interact with OXISTAT Lotion? Potential drug interactions between OXISTAT and other drugs have not been studied. How should I store OXISTAT Lotion? Store OXISTAT Lotion between 15 and 30 C (59 and 86 F) PharmaDerm A division of Fougera Pharmaceuticals Inc. Melville, NY 11747 USA www.pharmaderm.com OXISTAT is a registered trademark of Fougera Pharmaceuticals Inc. 2017 Fougera Pharmaceuticals Inc. All rights reserved. P-OXI-1347735 08/2017