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Dibucaine Topical 1% Ont 28 Gm

  • Manufacturer Name : Major
  • MFG # : 00536121195
  • NDC : 00536121195
  • Distributor Name : AmeriSource Bergen
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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 on the skin to stop itching and pain from certain skin conditions (such as scrapes, minor burns, eczema, insect bites) and to treat minor discomfort and itching caused by hemorrhoids. Dibucaine is a local anesthetic that works by causing temporary numbness/loss of feeling in the skin.
Drug Category N
Drug Type Code 2
FDA Approval Date 08/19/2019
FDA Therap Equiv NR
HCPCS -
HCPCS 2
Market Entry Date 08/26/2019
Medical Coverage -
Medical Coverage -
Termination Date -
Termination Date (DYE-bue-kane)
Unit GM
Units Per Pkg 28
Active Ingredients 1371 dibucaine 85790
Active Ingredients 1371 dibucaine 85790
AHFS Class 84080000 ANTIPRURITICS AND LOCAL ANESTHETICS
AHFS Class 84080000 ANTIPRURITICS AND LOCAL ANESTHETICS
DEA Class NC
DEA Class NC
Dose Form OINTMENT (GRAM)
Dose Form OINTMENT (GRAM)
Fine Line Class 250025502559 Gnrc Anti-Itch Treatments
Fine Line Class 250025502559 Gnrc Anti-Itch Treatments
Gen Code and Des 7484 dibucaine TOPICAL OINT. (G) 1 %
Gen Code and Des 7484 dibucaine TOPICAL OINT. (G) 1 %
Inactive Ingredients -
Inactive Ingredients -
OMP Family -
OMP Family -
Product Category OT Over the Counter
Product Category OT Over the Counter
Strength 1%
Strength 1%
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.
Drug Interaction -
Allocation Period -
Allocation Period -
Case Quantity 36
Case Quantity 36
Drug Form Pack Size 28
Drug Form Pack Size 28
Form OINTMENT
Form OINTMENT
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Orange Book ZB Particular pharmaceutical entity was not evaluated.
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 28
Unit Size 28
How to Use -
How to Use HOW TO USE: If you are using the over-the-counter product to self-treat, read all directions on the product package before using this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, use it as directed. Before use on the skin, clean and dry the affected area as directed. Apply a thin layer of medication to the affected area of skin as directed, usually 3 to 4 times a day. Do not use on large areas of the body or apply heat unless directed to do so by your doctor. These may increase the risk of serious side effects. Wash hands immediately after use unless you are treating an area on the hands. Avoid getting the product in eyes, nose, or ears. If the medication gets in these areas, rinse the area immediately with clean water. The dosage is based on your medical condition and response to treatment. Do not use more of this product, use it more often, or keep using it longer than directed. If there is an infection or sore in the area to be treated, do not use this medication without consulting your doctor first. If your condition lasts or gets worse, or if you think you may have a serious medical problem, get medical help right away.
Missed Dose 28
Missed Dose MISSED DOSE: If you are using this product on a regular schedule and 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: Keep all regular medical and lab appointments.
Overdose NR
Overdose OVERDOSE: This medicine may be harmful if inhaled or 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: drowsiness, irregular heartbeat, seizures.
Phonetic Pronunciation (DYE-bue-kane)
Phonetic Pronunciation -
Precautions -
Precautions PRECAUTIONS: Before using dibucaine, tell your doctor or pharmacist if you are allergic to it; or to other amide-type anesthetics (such as lidocaine, 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 or pharmacist your medical history, especially of: broken skin/infection in the area where dibucaine is to be used, heart disease, liver disease, a certain blood disorder (methemoglobinemia). 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. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Temporary redness, stinging, and a little bit of swelling may occur at the application site. If any of these effects last or get worse, tell 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. Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, seizures, 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 any 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 -
Storage 08/19/2019
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: This medication is used on the skin to stop itching and pain from certain skin conditions (such as scrapes, minor burns, eczema, insect bites) and to treat minor discomfort and itching caused by hemorrhoids. Dibucaine is a local anesthetic that works by causing temporary numbness/loss of feeling in the skin.
Uses -

Frequently Asked Questions(FAQs)

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Dibucaine Topical 1% Ont 28 Gm is manufactured by Major.
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