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Ketoconazole Cream 2% 60Gm-Teva

  • Manufacturer Name : TEVA USA
  • MFG # : 00093-3219-92
  • NDC : 00093321992
  • Distributor Name : AmeriSource Bergen
  • UPC : 300933219921
  • GTIN : 20300933219925
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind AB
Drug Category -
Drug Type Code N
FDA Approval Date 02/19/2019
FDA Therap Equiv GM
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit 60
Units Per Pkg 04/25/2000
Active Ingredients 2903 ketoconazole 65277421
AHFS Class 84040808 AZOLES (SKIN AND MUCOUS MEMBRANE)
DEA Class NC
Dose Form CREAM (GRAM)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 7334 ketoconazole TOPICAL CREAM (G) 2 %
Inactive Ingredients 2468 propylene glycol 57556; 6300 sulfite 14265453; 7543 sorbitan esters
OMP Family -
Product Category RX Pharmaceuticals
Strength 2%
Common Brand Name COMMON BRAND NAME(S): Nizoral
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 70
Drug Form Pack Size 60
Form CREAM
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 60
How to Use HOW TO USE: Use this medication on the skin only. Clean and thoroughly dry the area to be treated. Apply this medication to the affected skin, usually once or twice a day or as directed by your doctor. Dosage and length of treatment depends on the type of infection being treated. Do not apply this more often than prescribed. Your condition will not clear faster, but side effects may be increased. Apply enough medication to cover the affected skin and some of the surrounding skin. After applying this medication, wash your hands. Do not wrap, cover or bandage the area unless directed to do so by your doctor. Do not apply this medication in the eyes, nose, mouth, or vagina. If this medication gets in the eyes (for example, when used to treat dandruff), rinse thoroughly with water. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting ketoconazole. Stopping the medication too early may allow the fungus to continue to grow, which may result in a relapse of the infection. Inform your doctor if your condition lasts after the prescribed amount of treatment or gets worse at any time.
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 infection unless your doctor tells you to. When treating pityriasis, this medication may not cause an immediate return to normal skin color. It may take several months after treatment is completed for your natural skin color to return.
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, econazole, or 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 should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Stinging, swelling, irritation, or redness of the treated skin may occur. If any of these effects last or get worse, notify 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. Tell your doctor right away if you have any serious side effects, including: blistering, open sores. 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. 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: Ketoconazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and certain kinds of dandruff. This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Ketoconazole is an azole antifungal that works by preventing the growth of fungus.

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Ketoconazole Cream 2% 60Gm-Teva is manufactured by TEVA USA.
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