Product Details
CICLOPIROX GEL 0.77% 100-PADAGIS
Manufacturer: Padagis US LLC
MFG#: 00574-2061-01
NDC: 00574-2061-01
PID: 212038
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Product Properties:
| Description | - |
|---|---|
| DESI Drug Ind | - |
| DESI2 Drug Ind | AB |
| Drug Category | NJ |
| Drug Type Code | N |
| FDA Approval Date | 12/14/2010 |
| FDA Therap Equiv | GM |
| HCPCS | - |
| Market Entry Date | - |
| Medical Coverage | - |
| Termination Date | 1 |
| Unit | 100 |
| Units Per Pkg | 01/07/2009 |
| Active Ingredients | 4961 ciclopirox 29342050 |
| AHFS Class | 84040820 HYDROXYPYRIDONES (SKIN, MUCOUS MEMBRANE) |
| DEA Class | NC |
| Dose Form | GEL (GRAM) |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 44922 ciclopirox TOPICAL GEL (GRAM) 0.77 % |
| Inactive Ingredients | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Strength | 0.77% |
| Common Brand Name | COMMON BRAND NAME(S): Loprox |
| 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 | 12 |
| Drug Form Pack Size | 100 |
| Form | GELATIN |
| Hazard Code | UN1987 ALCOHOLS, N.O.S. |
| Listed Chemical | - |
| NIOSH Code | - |
| Orange Book | AB Products meeting necessary bioequivalence requirements. |
| Retail Pack Quantity | 1 |
| Returnable Status | Returnable |
| Special Storage Cond | 02 Alcohol |
| Temp Zone | 20 Cool-Store Cont Temp |
| Unit | EA |
| Unit Size | 100 |
| How to Use | HOW TO USE: Use this medication on the skin only. Clean and dry the area to be treated. Apply a thin layer of the medication on and around the affected area and gently rub into the skin or scalp as directed by your doctor, usually twice daily. Wash your hands after using unless the area being treated includes the hands. Do not wrap, cover, or bandage the area unless directed to do so by your doctor. Do not apply the medication in the eyes, nose, or mouth, or inside the vagina. If you do get the medication in those areas, rinse with plenty of water. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue to use this medication for the full time prescribed, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition worsens or does not improve after 4 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. |
| 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 infection unless told to do so by your doctor. A different medication may be necessary in that case. If you are treating athlete's foot, make sure to wear well-fitting, ventilated shoes. Also, change socks at least once daily. |
| 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 | (cyc-low-PIE-rocks) |
| Precautions | PRECAUTIONS: Before using ciclopirox, tell your doctor or pharmacist if you are allergic to it; 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. Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. |
| Side Effects | SIDE EFFECTS: Burning, stinging, redness, or itching at the application site may occur. 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: blistering/swelling/oozing at the application site. 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. 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 certain fungal skin infections such as ringworm and athlete's foot between the toes. It is also used to treat a certain scalp condition (seborrheic dermatitis). Ciclopirox is an antifungal medication that works by stopping the growth of fungus. |
Frequently Asked Questions (FAQs)
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CICLOPIROX GEL 0.77% 100-PADAGIS is manufactured by Padagis US LLC.
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