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Ketoconazole Foam 2% 100Gm-Xiromed

  • Manufacturer Name : Xiromed LLC
  • MFG # : 70700-0160-20
  • NDC : 70700016020
  • Distributor Name : AmeriSource Bergen
  • UPC : 370700160206
  • GTIN : 10370700160203
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind AT
Drug Category -
Drug Type Code N
FDA Approval Date 08/02/2021
FDA Therap Equiv GM
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit 100
Units Per Pkg 05/21/2021
Active Ingredients 2903 ketoconazole 65277421
AHFS Class 84040808 AZOLES (SKIN AND MUCOUS MEMBRANE)
DEA Class NC
Dose Form FOAM (GRAM)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 63088 ketoconazole TOPICAL FOAM 2 %
Inactive Ingredients 2468 propylene glycol 57556
OMP Family -
Product Category RX Pharmaceuticals
Strength 2%
Common Brand Name COMMON BRAND NAME(S): Extina
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Case Quantity 32
Drug Form Pack Size 100
Form FOAM
Hazard Code UN1950 AEROSOLS, FLAMMABLE, (EACH NOT EXCEEDING 1 L CAPACITY)
Listed Chemical -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 01 Aerosol
Temp Zone 10 Room Temperature
Unit EA
Unit Size 100
How to Use HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using ketoconazole and each time you get a refill. If you have any questions, consult your doctor or pharmacist. If the can is warm or the foam is runny, place the can under cool running water for a few minutes before using. Use this medication on the skin only. Clean and thoroughly dry the area to be treated. To keep the medication from melting on your fingers, wash your hands with cold water and dry thoroughly before applying. Hold the can upright. Do not spray the medication directly on the affected area or on your hands. Instead, spray the medication into the cap of the can or some other cool, clean surface. Using your fingertips, pick up the medication and gently and thoroughly rub into the affected areas, usually 2 times daily for 4 weeks or as directed by your doctor. If treating the scalp, part your hair 1 section at a time, and apply the medication directly to the affected scalp area, not the hair. Do not apply this medication in the eyes, nose, mouth, or inside the vagina. If you do get the medication in those areas, flush with plenty of water. Wash your hands after applying the medication. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Tell your doctor if your condition worsens or does not improve after 4 weeks of treatment.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another skin condition unless told to do so by your doctor. A different medication may be necessary in that case.
Overdose OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (kee-toe-CON-uh-zole)
Precautions PRECAUTIONS: Before using ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals (such as clotrimazole, miconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk when applied to the skin. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Burning or irritation at the application site may occur. If either of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from heat. Do not store in the refrigerator or freezer. This product is flammable. Do not store or use near an open flame. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is used to treat a certain skin condition (seborrheic dermatitis). In this condition, it is believed that a fungus (Malassezia furfur) infects the skin, resulting in dry, flaky skin (scaling) on the scalp, face, ears, chest, or upper back. Ketoconazole is an azole antifungal drug that works by stopping the growth of fungus.

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Ketoconazole Foam 2% 100Gm-Xiromed is manufactured by Xiromed LLC.
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