Product Details
HYDROCORTISONE 2.5% ONT 454 GM
Manufacturer: Padagis US LLC
MFG#: 45802-0014-05
NDC: 45802-0014-05
PID: 242620
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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 | NJ |
| Drug Type Code | N |
| Drug Type Code | 1 |
| FDA Approval Date | 09/30/1990 |
| FDA Approval Date | 09/30/1990 |
| FDA Therap Equiv | AT |
| FDA Therap Equiv | GM |
| HCPCS | - |
| HCPCS | - |
| Market Entry Date | 09/30/1990 |
| Market Entry Date | - |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | - |
| Termination Date | 1 |
| Unit | GM |
| Unit | 453 |
| Units Per Pkg | 09/30/1990 |
| Units Per Pkg | 453 |
| Active Ingredients | 2147 hydrocortisone 50237 |
| Active Ingredients | 2147 hydrocortisone 50237 |
| AHFS Class | 84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE) |
| AHFS Class | 84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE) |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | OINTMENT (GRAM) |
| Dose Form | OINTMENT (GRAM) |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 7548 hydrocortisone TOPICAL OINT. (G) 2.5 % |
| Gen Code and Des | 7548 hydrocortisone TOPICAL OINT. (G) 2.5 % |
| Inactive Ingredients | - |
| Inactive Ingredients | - |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 2.5% |
| Strength | 2.5% |
| Common Brand Name | COMMON BRAND NAME(S): Aquanil HC, Cetacort, Cortaid, Hytone |
| Common Brand Name | COMMON BRAND NAME(S): Aquanil HC, Cetacort, Cortaid, Hytone |
| 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 | 12 |
| Case Quantity | 12 |
| Drug Form Pack Size | 454 |
| Drug Form Pack Size | 454 |
| Form | OINTMENT |
| Form | OINTMENT |
| 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 | 454 |
| Unit Size | 454 |
| How to Use | HOW TO USE: There are many hydrocortisone products available. Many can be purchased without a prescription. Some products require a prescription. Consult your doctor or pharmacist on the choice of the product that is best for you. Use this medication on the skin only. However, do not use it on the face or underarms unless directed to do so by your doctor. Some products are meant to be used on the scalp for various conditions. To correctly use these products, follow the directions on the product package. Wash and dry your hands before using. Clean and dry the affected area. If you are using the lotion or foam, shake it well just before using. If you are using the spray, check the product package to see if it needs to be shaken before each use. Apply a small amount of medication to the affected area and gently rub in, usually up to 4 times a day or as directed by your doctor or the product package. Dosage and length of treatment depends on the type of condition being treated. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. If used in or near the diaper area on an infant, do not use tight-fitting diapers or plastic pants. After applying the medication, wash your hands, unless the hands are being treated. Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water. If irritation occurs or continues, contact your doctor right away. Use this medication only for the condition for which it was prescribed or a condition that is listed on the product package. Do not use it for longer than directed by the product package or your doctor. Tell your doctor if your condition lasts or gets worse after 7 days or if you think you may have a serious medical problem. |
| How to Use | HOW TO USE: There are many hydrocortisone products available. Many can be purchased without a prescription. Some products require a prescription. Consult your doctor or pharmacist on the choice of the product that is best for you. Use this medication on the skin only. However, do not use it on the face or underarms unless directed to do so by your doctor. Some products are meant to be used on the scalp for various conditions. To correctly use these products, follow the directions on the product package. Wash and dry your hands before using. Clean and dry the affected area. If you are using the lotion or foam, shake it well just before using. If you are using the spray, check the product package to see if it needs to be shaken before each use. Apply a small amount of medication to the affected area and gently rub in, usually up to 4 times a day or as directed by your doctor or the product package. Dosage and length of treatment depends on the type of condition being treated. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. If used in or near the diaper area on an infant, do not use tight-fitting diapers or plastic pants. After applying the medication, wash your hands, unless the hands are being treated. Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water. If irritation occurs or continues, contact your doctor right away. Use this medication only for the condition for which it was prescribed or a condition that is listed on the product package. Do not use it for longer than directed by the product package or your doctor. Tell your doctor if your condition lasts or gets worse after 7 days or if you think you may have a serious medical problem. |
| 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 prescribed by your doctor, use this medication 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. Keep all medical and lab appointments. |
| Notes | NOTES: Do not share this medication with others. If prescribed by your doctor, use this medication 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. Keep all medical and lab appointments. |
| 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 | (HYE-droe-KOR-ti-sone) |
| Phonetic Pronunciation | (HYE-droe-KOR-ti-sone) |
| Precautions | PRECAUTIONS: Before using hydrocortisone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as prednisone, triamcinolone); 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. If you have any health problems, consult your doctor or pharmacist before using this product. If you have itching of the outer female genitals with vaginal discharge, consult your doctor before using this product. Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when this medication is used. Tell your doctor promptly if redness, swelling, or irritation does not improve. Children may be more sensitive to the effects of too much corticosteroid medication. Consult your doctor for more details. 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. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding. |
| Precautions | PRECAUTIONS: Before using hydrocortisone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as prednisone, triamcinolone); 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. If you have any health problems, consult your doctor or pharmacist before using this product. If you have itching of the outer female genitals with vaginal discharge, consult your doctor before using this product. Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when this medication is used. Tell your doctor promptly if redness, swelling, or irritation does not improve. Children may be more sensitive to the effects of too much corticosteroid medication. Consult your doctor for more details. 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. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding. |
| Side Effects | SIDE EFFECTS: Stinging, burning, irritation, dryness, or redness at the application site may occur. Acne, unusual hair growth, small red bumps on the skin (folliculitis), skin thinning/discoloration, or stretch marks may also occur. If any of these effects last or get worse, tell 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. If the treated area starts to bleed, especially if you are using this product for anal itching, contact your doctor right away. 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: Stinging, burning, irritation, dryness, or redness at the application site may occur. Acne, unusual hair growth, small red bumps on the skin (folliculitis), skin thinning/discoloration, or stretch marks may also occur. If any of these effects last or get worse, tell 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. If the treated area starts to bleed, especially if you are using this product for anal itching, contact your doctor right away. 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: Refer to the storage information printed on the package. Protect from light and moisture. If you have any questions about storage, ask your pharmacist. 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: Refer to the storage information printed on the package. Protect from light and moisture. If you have any questions about storage, ask your pharmacist. 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 variety of skin conditions (such as insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid. |
| Uses | USES: This medication is used to treat a variety of skin conditions (such as insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid. |
Frequently Asked Questions (FAQs)
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HYDROCORTISONE 2.5% ONT 454 GM is manufactured by Padagis US LLC.
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