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  • Manufacturer Name : TEVA USA
  • MFG # : 00591-2159-90
  • NDC : 00591215990
  • Distributor Name : AmeriSource Bergen
  • UPC : 305912159908
  • GTIN : 00305912159908
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Product Properties:

Description N
Description -
DESI Drug Ind $0.53; 04/01/2017
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Category USES: This medication is used to treat a certain scalp condition (seborrheic dermatitis). Ciclopirox is an antifungal drug that works by stopping the growth of fungus.
Drug Type Code COMMON BRAND NAME(S): Loprox
Drug Type Code 1
FDA Approval Date 11/24/2009
FDA Therap Equiv AT
HCPCS -
HCPCS 1
Market Entry Date 12/12/2012
Medical Coverage -
Medical Coverage -
Termination Date -
Termination Date (sye-kloe-PEER-ox)
Unit ML
Units Per Pkg 120
Active Ingredients 4961 ciclopirox 29342050
Active Ingredients 4961 ciclopirox 29342050
AHFS Class 84040820 HYDROXYPYRIDONES (SKIN, MUCOUS MEMBRANE)
AHFS Class 84040820 HYDROXYPYRIDONES (SKIN, MUCOUS MEMBRANE)
DEA Class NC
DEA Class NC
Dose Form SHAMPOO
Dose Form SHAMPOO
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 51825 ciclopirox TOPICAL SHAMPOO 1 %
Gen Code and Des 51825 ciclopirox TOPICAL SHAMPOO 1 %
Inactive Ingredients -
Inactive Ingredients -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 1%
Strength 1%
Common Brand Name COMMON BRAND NAME(S): Loprox
Common Brand Name -
Drug Interaction -
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 24
Case Quantity 24
Drug Form Pack Size 120
Drug Form Pack Size 120
Form SHAMPOO
Form SHAMPOO
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 120
Unit Size 120
How to Use -
How to Use HOW TO USE: This medication is for use on the hair and scalp only. Wet hair and scalp with water. Apply about one teaspoonful (5 milliliters) of this product to wet hair and massage it over your entire scalp until it forms a lather. For long hair, two teaspoonfuls (10 milliliters) of the product may be used. Leave the medication on the scalp and hair for 3 minutes. Then rinse the medication off completely. Avoid getting this medication in the eyes, nose, mouth, or vaginal area. If you do get medication into these areas, rinse with plenty of water. Use this medication as directed by your doctor, usually 2 times a week with at least 3 days between each use. Use this medication regularly in order to get the most benefit from it. Mark the days on the calendar when you need to use the medication. Continue to use this medication for the full amount of time prescribed, even if symptoms disappear after a few days. Tell your doctor if your condition worsens or does not improve after 4 weeks.
Missed Dose 120
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. Do not double the dose to catch up. Wait at least 3 days between uses of the drug. If you have any questions, ask your doctor or pharmacist right away for a new dosing schedule.
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 condition unless told to do so by your doctor. A different medication may be necessary in that case.
Notes ML
Overdose AT
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 -
Phonetic Pronunciation (sye-kloe-PEER-ox)
Precautions -
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 SIDE EFFECTS: Burning, redness, or itching at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. In people with light-colored hair, changes in hair color have rarely occurred. 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 11/24/2009
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 USES: This medication is used to treat a certain scalp condition (seborrheic dermatitis). Ciclopirox is an antifungal drug that works by stopping the growth of fungus.

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