Product Details
MICONAZOLE 2% CRM 28GM
Manufacturer: H2-PHARMA,LLC -E
MFG#: 61269-0735-56
NDC: 61269-0735-56
PID: 320189
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Product Properties:
| Description | - |
|---|---|
| Description | - |
| Description | - |
| DESI Drug Ind | - |
| DESI Drug Ind | - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | NR |
| DESI2 Drug Ind | NR |
| DESI2 Drug Ind | - |
| Drug Category | N |
| Drug Category | - |
| Drug Category | - |
| Drug Type Code | N |
| Drug Type Code | 2 |
| Drug Type Code | N |
| FDA Approval Date | 06/01/1997 |
| FDA Approval Date | 06/01/1997 |
| FDA Approval Date | 06/01/1997 |
| FDA Therap Equiv | GM |
| FDA Therap Equiv | GM |
| FDA Therap Equiv | NR |
| HCPCS | - |
| HCPCS | - |
| HCPCS | - |
| Market Entry Date | - |
| Market Entry Date | 06/01/1997 |
| Market Entry Date | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | 2 |
| Termination Date | - |
| Termination Date | 2 |
| Unit | GM |
| Unit | 28 |
| Unit | 28 |
| Units Per Pkg | 06/01/1997 |
| Units Per Pkg | 06/01/1997 |
| Units Per Pkg | 28 |
| Active Ingredients | 2919 miconazole nitrate 22832877 |
| Active Ingredients | 2919 miconazole nitrate 22832877 |
| Active Ingredients | 2919 miconazole nitrate 22832877 |
| AHFS Class | 84040808 AZOLES (SKIN AND MUCOUS MEMBRANE) |
| AHFS Class | 84040808 AZOLES (SKIN AND MUCOUS MEMBRANE) |
| AHFS Class | 84040808 AZOLES (SKIN AND MUCOUS MEMBRANE) |
| DEA Class | NC |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | CREAM (GRAM) |
| Dose Form | CREAM (GRAM) |
| Dose Form | CREAM (GRAM) |
| Fine Line Class | 270027402749 Gnrc Antifungal Treatments |
| Fine Line Class | 270027402749 Gnrc Antifungal Treatments |
| Fine Line Class | 270027402749 Gnrc Antifungal Treatments |
| Gen Code and Des | 7366 miconazole nitrate TOPICAL CREAM (G) 2 % |
| Gen Code and Des | 7366 miconazole nitrate TOPICAL CREAM (G) 2 % |
| Gen Code and Des | 7366 miconazole nitrate TOPICAL CREAM (G) 2 % |
| Inactive Ingredients | - |
| Inactive Ingredients | - |
| Inactive Ingredients | - |
| OMP Family | - |
| OMP Family | - |
| OMP Family | - |
| Product Category | OT Over the Counter |
| Product Category | OT Over the Counter |
| Product Category | OT Over the Counter |
| Strength | 2% |
| Strength | 2% |
| Strength | 2% |
| Common Brand Name | COMMON BRAND NAME(S): Lotrimin AF, Micatin, Monistat Derm |
| Common Brand Name | COMMON BRAND NAME(S): Lotrimin AF, Micatin, Monistat Derm |
| Common Brand Name | COMMON BRAND NAME(S): Lotrimin AF, Micatin, Monistat Derm |
| 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. |
| 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. |
| 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 | - |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 48 |
| Case Quantity | 48 |
| Case Quantity | 48 |
| Drug Form Pack Size | 28 |
| Drug Form Pack Size | 28 |
| Drug Form Pack Size | 28 |
| Form | CREAM |
| Form | CREAM |
| Form | CREAM |
| Hazard Code | - |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| Listed Chemical | - |
| NIOSH Code | - |
| NIOSH Code | - |
| NIOSH Code | - |
| Orange Book | ZB Particular pharmaceutical entity was not evaluated. |
| Orange Book | ZB Particular pharmaceutical entity was not evaluated. |
| Orange Book | ZB Particular pharmaceutical entity was not evaluated. |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit | EA |
| Unit | EA |
| Unit Size | 28 |
| Unit Size | 28 |
| Unit Size | 28 |
| 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 twice a day or as directed by your doctor. If you are using the spray form, shake the bottle well before applying. 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 area 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. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting miconazole. 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 or gets worse. |
| 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 twice a day or as directed by your doctor. If you are using the spray form, shake the bottle well before applying. 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 area 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. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting miconazole. 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 or gets worse. |
| 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 twice a day or as directed by your doctor. If you are using the spray form, shake the bottle well before applying. 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 area 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. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after starting miconazole. 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 or gets worse. |
| 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. |
| 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. |
| 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. If your doctor has directed you to use this medication, use it 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. |
| Notes | NOTES: Do not share this medication with others. If your doctor has directed you to use this medication, use it 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. |
| Notes | NOTES: Do not share this medication with others. If your doctor has directed you to use this medication, use it 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. |
| 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. |
| 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 | (mye-KON-a-zole) |
| Phonetic Pronunciation | (mye-KON-a-zole) |
| Phonetic Pronunciation | (mye-KON-a-zole) |
| Precautions | PRECAUTIONS: Before using miconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, econazole, or ketoconazole; 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. 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. Consult your doctor before breast-feeding. |
| Precautions | PRECAUTIONS: Before using miconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, econazole, or ketoconazole; 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. 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. Consult your doctor before breast-feeding. |
| Precautions | PRECAUTIONS: Before using miconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, econazole, or ketoconazole; 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. 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. Consult your doctor before breast-feeding. |
| Side Effects | SIDE EFFECTS: Burning, stinging, swelling, irritation, redness, pimple-like bumps, tenderness, or flaking of the treated skin may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly. If your doctor has directed you to use this medication, remember that 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, oozing, 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. |
| Side Effects | SIDE EFFECTS: Burning, stinging, swelling, irritation, redness, pimple-like bumps, tenderness, or flaking of the treated skin may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly. If your doctor has directed you to use this medication, remember that 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, oozing, 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. |
| Side Effects | SIDE EFFECTS: Burning, stinging, swelling, irritation, redness, pimple-like bumps, tenderness, or flaking of the treated skin may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly. If your doctor has directed you to use this medication, remember that 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, oozing, 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: Different brands/strengths of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Protect from light. For the gel and spray, also protect from open flame and heat. 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. |
| Storage | STORAGE: Different brands/strengths of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Protect from light. For the gel and spray, also protect from open flame and heat. 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. |
| Storage | STORAGE: Different brands/strengths of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Protect from light. For the gel and spray, also protect from open flame and heat. 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: Miconazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). 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. Miconazole is an azole antifungal that works by preventing the growth of fungus. |
| Uses | USES: Miconazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). 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. Miconazole is an azole antifungal that works by preventing the growth of fungus. |
| Uses | USES: Miconazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). 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. Miconazole is an azole antifungal that works by preventing the growth of fungus. |
Frequently Asked Questions (FAQs)
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MICONAZOLE 2% CRM 28GM is manufactured by H2-PHARMA,LLC -E.
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