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FINACEA 15% FOM 50 GM

  • Manufacturer Name : LEO PHARMA INC.
  • MFG # : 50222030350
  • NDC : 50222030350
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind -
DESI2 Drug Ind NR
Drug Category -
Drug Category S
Drug Type Code 1
Drug Type Code S
FDA Approval Date 09/18/2015
FDA Approval Date 08/03/2015
FDA Therap Equiv NR
FDA Therap Equiv GM
HCPCS -
HCPCS -
Market Entry Date 09/18/2015
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date -
Termination Date 1
Unit 50
Unit GM
Units Per Pkg 50
Units Per Pkg 08/03/2015
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 FOAM (GRAM)
Dose Form FOAM (GRAM)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 74590 azelaic acid TOPICAL FOAM 15 %
Gen Code and Des 74590 azelaic acid TOPICAL FOAM 15 %
Inactive Ingredients 2468 propylene glycol 57556
Inactive Ingredients 2468 propylene glycol 57556
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 COMMON BRAND NAME(S): Finacea
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 48
Case Quantity 48
Drug Form Pack Size 50
Drug Form Pack Size 50
Form FOAM
Form FOAM
Hazard Code UN1950 AEROSOLS, FLAMMABLE, (EACH NOT EXCEEDING 1 L CAPACITY)
Hazard Code UN1950 AEROSOLS, FLAMMABLE, (EACH NOT EXCEEDING 1 L CAPACITY)
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 01 Aerosol
Special Storage Cond 01 Aerosol
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: Apply this medication on your face as directed by your doctor, usually twice daily. To avoid irritation, avoid contact with your eyes or inside the nose or mouth. If you accidentally get this medication in your eyes, flush well with cool water. Call your doctor if eye irritation does not go away. Before use, wash the affected area with a mild soap or soap-free cleanser and pat dry. Avoid using other skin care products that may irritate your skin, such as astringents, abrasives, tinctures, cleansers that contain alcohol, and products that cause skin peeling. Shake the container well before each use. Use your fingers to apply a thin layer of medication over your whole face (cheeks, chin, forehead, and nose) and gently massage the foam into your skin. Wash your hands after each use. Makeup may be applied after the medication has dried. Do not use any dressing or covering on the treated area unless directed by your doctor. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not use more of this medication or use this drug more often or for longer than prescribed. Your skin will not improve any faster, and your risk of side effects will increase. Tell your doctor if your condition does not get better after 12 weeks or if it gets worse.
How to Use HOW TO USE: Apply this medication on your face as directed by your doctor, usually twice daily. To avoid irritation, avoid contact with your eyes or inside the nose or mouth. If you accidentally get this medication in your eyes, flush well with cool water. Call your doctor if eye irritation does not go away. Before use, wash the affected area with a mild soap or soap-free cleanser and pat dry. Avoid using other skin care products that may irritate your skin, such as astringents, abrasives, tinctures, cleansers that contain alcohol, and products that cause skin peeling. Shake the container well before each use. Use your fingers to apply a thin layer of medication over your whole face (cheeks, chin, forehead, and nose) and gently massage the foam into your skin. Wash your hands after each use. Makeup may be applied after the medication has dried. Do not use any dressing or covering on the treated area unless directed by your doctor. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not use more of this medication or use this drug more often or for longer than prescribed. Your skin will not improve any faster, and your risk of side effects will increase. Tell your doctor if your condition does not get better after 12 weeks or if it gets worse.
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. To help manage rosacea, avoid foods or liquids that may bring on redness, flushing, or blushing of the skin (such as spicy foods, alcohol, hot drinks).
Notes NOTES: Do not share this medication with others. To help manage rosacea, avoid foods or liquids that may bring on redness, flushing, or blushing of the skin (such as spicy foods, alcohol, hot drinks).
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 (ay-ze-LAY-ik AS-id)
Phonetic Pronunciation (ay-ze-LAY-ik AS-id)
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, 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 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, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
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, 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 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, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Skin burning, stinging, tingling, or itching 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. Rarely, some people have had unusual loss of skin color (hypopigmentation) after using this medication. This side effect may be easier to see in people with dark skin color. Tell your doctor right away if you notice this side effect. 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: Skin burning, stinging, tingling, or itching 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. Rarely, some people have had unusual loss of skin color (hypopigmentation) after using this medication. This side effect may be easier to see in people with dark skin color. Tell your doctor right away if you notice this side effect. 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 and open flame. The contents of this can are flammable and under pressure. Do not puncture or burn the container. The product should be discarded 8 weeks after opening. 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: Store at room temperature away from heat and open flame. The contents of this can are flammable and under pressure. Do not puncture or burn the container. The product should be discarded 8 weeks after opening. 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 certain skin disorder known as rosacea, a type of adult acne. It helps to decrease redness, swelling, and the number of pimples caused by rosacea.
Uses USES: This medication is used to treat a certain skin disorder known as rosacea, a type of adult acne. It helps to decrease redness, swelling, and the number of pimples caused by rosacea.

Frequently Asked Questions(FAQs)

The cost of FINACEA 15% FOM 50 GM is available for registerd members only .
FINACEA 15% FOM 50 GM is manufactured by LEO PHARMA INC..
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