Product Details
CLOBETASOL PROPIONATE 0.05% SOL 25 ML
Manufacturer: Micro Labs Limited
MFG#: 42571-0362-81
NDC: 42571-0362-81
PID: 234790
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Product Properties:
| Description | - |
|---|---|
| Description | - |
| DESI Drug Ind | - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | AT |
| DESI2 Drug Ind | - |
| Drug Category | N |
| Drug Category | - |
| Drug Type Code | N |
| Drug Type Code | 1 |
| FDA Approval Date | 10/02/2019 |
| FDA Approval Date | 01/20/2020 |
| FDA Therap Equiv | ML |
| FDA Therap Equiv | AT |
| HCPCS | - |
| HCPCS | - |
| Market Entry Date | 01/20/2020 |
| Market Entry Date | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | - |
| Termination Date | 1 |
| Unit | 1 |
| Unit | ML |
| Units Per Pkg | 10/02/2019 |
| Units Per Pkg | 1 |
| Active Ingredients | 2203 clobetasol propionate 25122467 |
| Active Ingredients | 2203 clobetasol propionate 25122467 |
| AHFS Class | 84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE) |
| AHFS Class | 84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE) |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | SOLUTION, NON-ORAL |
| Dose Form | SOLUTION, NON-ORAL |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 15349 clobetasol propionate TOPICAL SOLUTION 0.05 % |
| Gen Code and Des | 15349 clobetasol propionate TOPICAL SOLUTION 0.05 % |
| Inactive Ingredients | - |
| Inactive Ingredients | - |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 0.05% |
| Strength | 0.05% |
| Common Brand Name | COMMON BRAND NAME(S): Cormax, Temovate |
| Common Brand Name | COMMON BRAND NAME(S): Cormax, Temovate |
| 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 | - |
| Case Quantity | 48 |
| Case Quantity | 48 |
| Drug Form Pack Size | 25 |
| Drug Form Pack Size | 25 |
| Form | SOLUTION |
| Form | SOLUTION |
| Hazard Code | - |
| Hazard Code | - |
| Listed Chemical | - |
| Listed Chemical | - |
| NIOSH Code | - |
| NIOSH Code | - |
| Orange Book | AT Topical products therapeutically equivalent in same dosage form. |
| Orange Book | AT Topical products therapeutically equivalent in same dosage form. |
| Retail Pack Quantity | 1 |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Returnable Status | Returnable |
| Special Storage Cond | 00 None |
| Special Storage Cond | 00 None |
| Temp Zone | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit | EA |
| Unit Size | 25 |
| Unit Size | 25 |
| How to Use | HOW TO USE: Apply this medication to the affected area of the scalp as directed by your doctor, usually twice daily (in the morning and evening). Use this medication only on the skin. However, do not use it on the face, groin or underarms unless directed to do so by your doctor. Wash and dry your hands before applying. Apply the prescribed amount of medication to the affected area and gently rub in. Do not bandage, wrap or cover the area. After applying the medication, wash your hands, unless you are using this medication to treat the hands. If applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting the medication in your nose or mouth. If you get the medication in your eyes, nose, or mouth, rinse with plenty of water. Use this medication exactly as prescribed. Do not increase your dose, take it more often, or use it for longer than 2 weeks in a row. Do not apply more than 50 milliliters of medication in a given week unless directed by your doctor. Doing so could increase your risk of side effects. Tell your doctor if your condition lasts or gets worse after 2 weeks. |
| How to Use | HOW TO USE: Apply this medication to the affected area of the scalp as directed by your doctor, usually twice daily (in the morning and evening). Use this medication only on the skin. However, do not use it on the face, groin or underarms unless directed to do so by your doctor. Wash and dry your hands before applying. Apply the prescribed amount of medication to the affected area and gently rub in. Do not bandage, wrap or cover the area. After applying the medication, wash your hands, unless you are using this medication to treat the hands. If applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting the medication in your nose or mouth. If you get the medication in your eyes, nose, or mouth, rinse with plenty of water. Use this medication exactly as prescribed. Do not increase your dose, take it more frequently, or use it for longer than 2 weeks in a row. Do not apply more than 50 milliliters of medication in a given week unless directed by your doctor. Doing so could increase your risk of side effects. Tell your doctor if your condition lasts or gets worse after 2 weeks. |
| 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. This medication has been prescribed for your current condition only. Do not use it later for other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases. Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for an extended period of time or apply it over large areas of the body. Keep all medical and lab appointments. Consult your doctor for more details. |
| 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 other skin problems unless told to do so by your doctor. A different medication may be necessary in those cases. Lab and/or medical tests (such as adrenal gland function) may be done while you are using this medication, especially if you use this drug for an extended period of time or apply it over large areas of the body. Keep all medical and lab appointments. Consult your doctor for more details. |
| Overdose | OVERDOSE: 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. This medicine may be harmful if swallowed. |
| Overdose | OVERDOSE: 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. This medicine may be harmful if swallowed. |
| Phonetic Pronunciation | (kloh-BAY-tuh-sol) |
| Phonetic Pronunciation | (kloh-BAY-tuh-sol) |
| Precautions | PRECAUTIONS: Before using clobetasol, tell your doctor or pharmacist if you are allergic to it; or to any other steroids (such as hydrocortisone, dexamethasone); 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, especially of: poor blood circulation, diabetes, other skin/scalp conditions (such as rosacea, perioral dermatitis), immune system problems. Do not use if there is an infection or sore in the area to be treated. Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked. 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 scalp/skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding. |
| Precautions | PRECAUTIONS: Before using clobetasol, tell your doctor or pharmacist if you are allergic to it; or to any other steroids (such as hydrocortisone, dexamethasone); 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, especially of: poor blood circulation, diabetes, other skin/scalp conditions (such as rosacea, perioral dermatitis), immune system problems. Do not use if there is an infection or sore in the area to be treated. Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months. Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked. 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 scalp/skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding. |
| Side Effects | SIDE EFFECTS: Burning, stinging, itching, irritation, dryness, or redness may occur when this medication is first applied to the scalp/skin. This should disappear in a few days as your body adjusts to the medication. If any 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. Tell your doctor right away if you have any serious side effects, including: stretch marks (striae), skin thinning/discoloration, excessive hair growth, acne, small red bumps on the skin (folliculitis). Skin infections can become worse when using this medication. Tell your doctor if redness, swelling or irritation does not improve. Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. 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, itching, irritation, dryness, or redness may occur when this medication is first applied to the scalp/skin. This should disappear in a few days as your body adjusts to the medication. If any 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. Tell your doctor right away if you have any serious side effects, including: stretch marks (striae), skin thinning/discoloration, excessive hair growth, acne, small red bumps on the skin (folliculitis). Skin infections can become worse when using this medication. Tell your doctor if redness, swelling or irritation does not improve. Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems. 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 and 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. |
| Storage | STORAGE: Store at room temperature away from heat and 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: Clobetasol is used to treat certain scalp and skin conditions (such as psoriasis, dermatitis, rash). Clobetasol reduces the swelling, itching and redness that can occur in these types of conditions. This medication is a very strong (super-high-potency) corticosteroid. |
| Uses | USES: Clobetasol is used to treat certain scalp and skin conditions (such as psoriasis, dermatitis, rash). Clobetasol reduces the swelling, itching and redness that can occur in these types of conditions. This medication is a very strong (super-high-potency) corticosteroid. |
Frequently Asked Questions (FAQs)
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CLOBETASOL PROPIONATE 0.05% SOL 25 ML is manufactured by Micro Labs Limited.
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