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Ketoconazole 2% Shampoo 4 Oz

  • Manufacturer Name : TOLMAR PHARMACE
  • MFG # : 63646001004
  • NDC : 63646001004
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description N
DESI Drug Ind $0.06; 04/01/2017
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Category USES: This medication is used to control dandruff. Use of this medication may help to relieve the flaking, scaling and itching associated with dandruff. Ketoconazole is an azole antifungal that works by preventing the growth of fungus. Ketoconazole 2% shampoo 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.
Drug Type Code 1
Drug Type Code COMMON BRAND NAME(S): Nizoral
FDA Approval Date 04/11/2005
FDA Therap Equiv AB
HCPCS -
HCPCS 1
Market Entry Date 04/11/2005
Medical Coverage -
Medical Coverage -
Termination Date (KEE-toe-KON-a-zole)
Termination Date -
Unit ML
Units Per Pkg 118
Active Ingredients 2903 ketoconazole 65277421
Active Ingredients 2903 ketoconazole 65277421
AHFS Class 84040808 AZOLES (SKIN AND MUCOUS MEMBRANE)
AHFS Class 84040808 AZOLES (SKIN AND 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 15568 ketoconazole TOPICAL SHAMPOO 2 %
Gen Code and Des 15568 ketoconazole TOPICAL SHAMPOO 2 %
Inactive Ingredients 10141 red dye
Inactive Ingredients 10141 red dye
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 2%
Strength 2%
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Nizoral
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 -
Allocation Period -
Allocation Period -
Case Quantity 12
Case Quantity 12
Drug Form Pack Size 118
Drug Form Pack Size 118
Form SHAMPOO
Form SHAMPOO
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
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 4
Unit Size 4
How to Use -
How to Use HOW TO USE: Wet hair and scalp completely with water. Apply enough shampoo to produce enough lather to clean hair and scalp. Massage gently over entire scalp. Rinse hair with warm water. Repeat this process if directed to do so by your doctor. Dry hair thoroughly after the final rinse. If using the over-the-counter strength of the shampoo (1%), apply the shampoo, lather, and rinse thoroughly. Repeat this process. Dry hair thoroughly after the second rinse. If treating skin other than the scalp, wet the skin and apply the shampoo to affected area and the surrounding healthy skin. Lather and leave in place for 5 minutes, then rinse off with water. Dosage, number of applications, and the length of treatment depends on the strength of the shampoo (2% or 1%) and the condition being treated. Carefully follow your doctor's instructions or the package directions. Avoid contact with the eyes. If the shampoo gets into the eyes, rinse thoroughly with water. Do not begin using the shampoo if your scalp/skin is broken or swollen. Inform your doctor if your condition lasts after 2-4 weeks of treatment or gets worse at any time.
Missed Dose 118
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 ML
Notes NOTES: This shampoo may remove the curl from a permanent wave in the hair. 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 AB
Phonetic Pronunciation (KEE-toe-KON-a-zole)
Phonetic Pronunciation -
Precautions PRECAUTIONS: Before using ketoconazole, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungals such as clotrimazole, econazole, or miconazole; 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. This medication should be used only if clearly needed during pregnancy. 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 -
Side Effects -
Side Effects SIDE EFFECTS: This medication may cause abnormal hair texture, discoloration, irritation, or pimple-like bumps on the scalp. There may also be oiliness or dryness of the hair and scalp. 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: hair loss. 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. 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 04/11/2005
Uses USES: This medication is used to control dandruff. Use of this medication may help to relieve the flaking, scaling and itching associated with dandruff. Ketoconazole is an azole antifungal that works by preventing the growth of fungus. Ketoconazole 2% shampoo 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.
Uses -

Frequently Asked Questions(FAQs)

The cost of Ketoconazole 2% Shampoo 4 Oz is available for registerd members only .
Ketoconazole 2% Shampoo 4 Oz is manufactured by TOLMAR PHARMACE.
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