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Product NDC Code | 27854-177 | ||||
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Drug Name | Anadent kanka gel |
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Type | Brand | ||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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Active Ingredients |
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Route | DENTAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 238910 | ||||
Application Number | part356 | ||||
Labeler Name | BELMORA LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Benzocaine 20%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Cut open tip of tube on score mark Adults and children 2 years of age and older: apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor Children under 12 years of age should be supervised in the use of this product Children under 2 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Ammonium Glycyrrhizate, Flavor, PEG-400, PEG-3350, Sodium Saccharin Dihydrate, Sorbic Acid
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses For the temporary relief of pain due to toothache To help protect against infection of minor oral irritation.
Purpose
Information about the drug product’s indications for use.Purpose oral pain reliever
Spl product data elements
Usually a list of ingredients in a drug product.Anadent Kanka Gel Benzocaine BENZOCAINE BENZOCAINE AMMONIUM GLYCYRRHIZATE POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM SORBIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Packaging BELMORA-177
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
20% BENZOCAINE TO RELIEVE ORAL PAIN COOLS GUM & RELIEVES IRRITATION For toothaches Toothache and Gum pain Relief Gel TAMPER-EVIDENT: Do not use if tube is cut prior to use. Retain carton for complete product information. Distributed by Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201 | www.anadentusa.com Questions/Comments please call: 1 888 779 2877 Monday to Friday 9AM - 5PM EST
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Do not use if tip is cut prior to opening This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted Do not use continuously This formula will stay in place for extended duration of relief Avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate shortness of breath • dizziness or lightheadedness • fatigue or lack of energy Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics Do not use more than directed • for more than 7 days unless told to do so by a dentist or doctor for teething • in children under 2 years of age Stop use and ask a dentist or doctor if swelling, rash or fever develops • irritation, pain or redness persists or worsens symptoms do not improve in 7 days • allergic reaction occurs Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API