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AZELAIC ACID GL 15% 50GM TOP

PID UOM Price Qty
651301 501/EA
$215.97
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Product Properties:

Description N
Description -
DESI Drug Ind -
DESI Drug Ind -; -
DESI2 Drug Ind -
Drug Category USES: This medication is used to treat a certain skin condition called rosacea. It helps to reduce the number of inflamed skin lesions.
Drug Category N
Drug Type Code 1
Drug Type Code COMMON BRAND NAME(S): Finacea
FDA Approval Date 08/23/2019
FDA Therap Equiv AB
HCPCS 1
HCPCS -
Market Entry Date 08/29/2019
Medical Coverage -
Medical Coverage -
Termination Date (ay-ze-LAY-ik AS-id)
Termination Date -
Unit GM
Units Per Pkg 50
Active Ingredients 3930 azelaic acid 123999
Active Ingredients 3930 azelaic acid 123999
AHFS Class 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
AHFS Class 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
DEA Class NC
DEA Class NC
Dose Form GEL (GRAM)
Dose Form GEL (GRAM)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 51812 azelaic acid TOPICAL GEL (GRAM) 15 %
Gen Code and Des 51812 azelaic acid TOPICAL GEL (GRAM) 15 %
Inactive Ingredients 13405 soy; 2468 propylene glycol 57556; 3785 edetic acid 60004
Inactive Ingredients 13405 soy; 2468 propylene glycol 57556; 3785 edetic acid 60004
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 15%
Strength 15%
Common Brand Name COMMON BRAND NAME(S): Finacea
Common Brand Name -
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. Avoid use of skin care products that can cause further irritation (such as cleansers that contain alcohol, tinctures, astringents, abrasives and peeling agents). Consult your doctor or pharmacist for details.
Drug Interaction -
Allocation Period -
Allocation Period -
Case Quantity 48
Case Quantity 48
Drug Form Pack Size 50
Drug Form Pack Size 50
Form GELATIN
Form GELATIN
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 50
Unit Size 50
How to Use -
How to Use HOW TO USE: This medication is for use only on the skin. Clean the affected area with a mild soap or soap-free cleanser and pat dry. Apply a thin layer of medication usually twice daily, or use as directed by your doctor. Gently massage the medication into the affected area. Wash your hands well after application. Make-up may be applied after the medication has dried. Avoid getting any of this medication in the eyes or inside the nose or mouth. If it does get in your eyes, wash them right away with plenty of water. Call your doctor if eye irritation lasts. Do not use large amounts or apply this product more often than directed. Your condition will not clear faster, but the chance for side effects may be increased. Improvement is usually seen within 4 weeks. However, it may take several weeks of continued use before the full effects of this medication are seen. Inform your doctor if your symptoms do not improve or worsen. Do not apply any dressing or covering over the treated area unless directed by your doctor.
Missed Dose 50
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 GM
Notes NOTES: Do not share this medication with others.
Overdose AB
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 (ay-ze-LAY-ik AS-id)
Precautions -
Precautions PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as propylene glycol), 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: asthma. Avoid any foods or liquids that may bring on redness, flushing or blushing of the skin (such as spicy foods, alcohol, hot drinks). Before having surgery, tell your doctor 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. This medication may pass into breast milk. Consult your doctor before breast-feeding.
Side Effects -
Side Effects SIDE EFFECTS: Burning, stinging, tingling or itching skin may occur during the first few weeks, but then subside as your body adjusts to this medication. If any of these effects last or get worse, notify 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: worsening of asthma symptoms (such as increased trouble breathing, increased use of quick-relief inhalers). This medication may rarely cause abnormal changes in skin color (hypopigmentation). Dark-skinned individuals may notice a lightening in skin color. Consult your doctor or pharmacist for advice and report these changes if they occur. 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. 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 08/23/2019
Uses -
Uses USES: This medication is used to treat a certain skin condition called rosacea. It helps to reduce the number of inflamed skin lesions.

Frequently Asked Questions(FAQs)

The cost of AZELAIC ACID GL 15% 50GM TOP is $215.97 .
AZELAIC ACID GL 15% 50GM TOP is manufactured by TARO PHARMACEUTICAL INDUSTRIES LTD.
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