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Sodium Fluoride 1.1 % Gel 56 Gm

  • Manufacturer Name : AVKARE
  • MFG # : 50268073356
  • NDC : 50268073356
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Type Code 1
FDA Approval Date 09/30/1990
FDA Therap Equiv NR
HCPCS -
Market Entry Date 09/30/2022
Medical Coverage -
Termination Date -
Unit GM
Units Per Pkg 56
Active Ingredients 1103 sodium fluoride 7681494
AHFS Class 92280000 CARIOSTATIC AGENTS
DEA Class NC
Dose Form GEL (GRAM)
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 2607 fluoride (sodium) DENTAL GEL (GRAM) 1.1 %
Inactive Ingredients 10138 blue dye; 10707 mint; 2600 saccharin 81072; 7989 peppermint
OMP Family -
Product Category RX Pharmaceuticals
Strength 1.1%
Common Brand Name COMMON BRAND NAME(S): Karidium, Karigel, Prevident
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 -
Case Quantity 24
Drug Form Pack Size 56
Form GELATIN
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 56
How to Use HOW TO USE: Use this medication once daily just before bedtime or as directed by your doctor/dentist. First brush your teeth thoroughly with toothpaste, and rinse as usual. Then apply a thin ribbon of this medication to your teeth with a toothbrush or mouth tray. Leave the medication on for at least 1 minute. Spit out the medication after use. Do not swallow. Children should rinse their mouth thoroughly right away. For adults, do not rinse your mouth, eat, or drink for at least 30 minutes after use to get the best results. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.
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. Using this medication does not replace good dental habits. Continue to brush and floss your teeth regularly as directed by your dentist, and have regular dental checkups.
Overdose OVERDOSE: 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: burning in the mouth, sore tongue, nausea, vomiting, diarrhea, increased saliva, stomach pain/cramping, muscle weakness, shaking, seizures.
Phonetic Pronunciation (SOE-dee-um FLOOR-ide)
Precautions PRECAUTIONS: Before using this medication, tell your doctor/dentist 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/dentist or pharmacist your medical history, especially of: mouth problems (such as sores, mucositis). Children may be more sensitive to the side effects of this drug, especially if this medication is swallowed. Watch children closely when they are using this medication to make sure that they do not swallow this medication. Tell your doctor if you are pregnant before using this medication. It is unknown if this drug passes into breast milk. Consult your healthcare professional before breast-feeding.
Side Effects SIDE EFFECTS: Mouth/gum irritation may rarely occur. If this effect lasts or gets worse, tell your doctor/dentist or pharmacist promptly. Tell your doctor/dentist right away if your teeth become stained or pitted. This is often a result of too much fluoride. Remember that this medication has been prescribed because your doctor or dentist 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. 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/dentist 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. 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 prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria.

Frequently Asked Questions(FAQs)

The cost of Sodium Fluoride 1.1 % Gel 56 Gm is available for registerd members only .
Sodium Fluoride 1.1 % Gel 56 Gm is manufactured by AVKARE.
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