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LIDOCAINE 5% ONT 50GM

  • Manufacturer Name : Amneal
  • MFG # : 65162091853
  • NDC : 65162091853
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind AT
Drug Category NJ
Drug Type Code N
FDA Approval Date 11/02/2015
FDA Therap Equiv GM
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit 50
Units Per Pkg 08/07/2015
Active Ingredients 1350 lidocaine 137586
AHFS Class 84080000 ANTIPRURITICS AND LOCAL ANESTHETICS
DEA Class NC
Dose Form OINTMENT (GRAM)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 14476 lidocaine TOPICAL OINT. (G) 5 %
Inactive Ingredients -
OMP Family -
Product Category RX Pharmaceuticals
Strength 5%
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. Tell your doctor or pharmacist if you are using other lidocaine products at the same time as this medication because your risk of serious side effects may increase.
Allocation Period -
Case Quantity 24
Drug Form Pack Size 50
Form OINTMENT
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AT Topical products therapeutically equivalent in same dosage form.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 20 Cool-Store Cont Temp
Unit EA
Unit Size 50
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using lidocaine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Before certain medical/dental procedures, this medication is usually applied by a health care professional. If you are applying this medication yourself, use as directed by your dentist or doctor. Avoid getting this medication in your eyes. Apply a thin layer, using the smallest amount needed to cover the affected area. The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on age and weight. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. If you are using lidocaine ointment to help relieve the pain from new dentures, apply the ointment with clean hands to all the surfaces of the dentures that touch your gums. To lessen the amount of lidocaine that may be swallowed, do not apply the ointment to the chewing surfaces of your dentures. Continue to consult your dentist regularly during the fitting process. Follow your dentist's instructions carefully. Wash your hands after use. When this medication is used in the mouth or throat, numbness may make swallowing difficult and increase your risk of swallowing the wrong way or choking. Do not chew gum or eat for 1 hour after using this product and while your mouth or throat is numb. It is especially important for children to not eat or chew gum for at least 1 hour after using this product. Be careful not to accidentally bite your tongue or mouth. If you are applying this medication to other mucous membranes or the skin, clean the affected area before use, if possible, and apply with clean hands as directed. For broken or burned skin, you may apply the ointment with a sterile gauze pad. Wash your hands after use unless you are treating an area on the hands. Lidocaine starts to numb the affected area within 5 minutes after application. If you are using this product before certain procedures, tell your doctor if the area does not feel numb or the numbness does not go away. If you are using this product to relieve pain/discomfort, tell your doctor if your condition lasts or gets worse.
Missed Dose MISSED DOSE: If you miss a dose, apply 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.
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. Symptoms of overdose may include: vision/hearing changes, severe dizziness/drowsiness, fainting, loss of consciousness, shaking, seizures, slow/irregular heartbeat, slow/shallow breathing.
Phonetic Pronunciation (LYE-doe-kane)
Precautions PRECAUTIONS: Before using lidocaine, tell your doctor, dentist, or pharmacist if you are allergic to it; or to other anesthetics (including amide-type anesthetics such as bupivacaine, prilocaine); 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, dentist, or pharmacist your medical history, especially of: cuts/sores/bleeding in the area where this drug will be applied, severe infection with high fever, heart problems (such as slow/irregular heartbeat, heart block), severe shock, liver disease, kidney disease, a certain blood disorder (methemoglobinemia). This drug may make you dizzy or drowsy or cause vision problems if you are using too much of it or are very sensitive to its effects. See Side Effects section. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children may be more sensitive to the side effects of this drug. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Mild stinging or burning 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. This medication may cause very serious side effects if you are using too much of it or are very sensitive to its effects. Stop using this medication and get medical help right away if you have any very serious side effects, including: dizziness, drowsiness, slow/shallow breathing, mental/mood changes (such as confusion, nervousness), shaking, seizures, vision changes (such as double/blurred vision), ringing in the ears, fainting, pale/bluish/gray skin, unusual tiredness, shortness of breath, fast/slow/irregular heartbeat. 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. Do not freeze. 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: Lidocaine is used to temporarily numb and relieve pain from minor burns (including sunburn), skin abrasions, insect bites, and other painful conditions affecting mucous membranes. Some lidocaine products are used to numb the lining of the mouth or throat before certain medical/dental procedures. It is also used to decrease pain while dentures are being fitted and while your gums are adjusting to the dentures. It should not be used long-term to decrease pain from poorly fitting dentures. Lidocaine belongs to a class of drugs called local anesthetics. This product should not be used to treat teething pain in infants and young children due to an increased risk of serious side effects. Talk to the doctor for more details and for other ways to treat teething pain.

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LIDOCAINE 5% ONT 50GM is manufactured by Amneal.
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