FDA Label for Anadent Kanka Gel
View Indications, Usage & Precautions
Anadent Kanka Gel Product Label
The following document was submitted to the FDA by the labeler of this product Belmora Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active Ingredient
Benzocaine 20%
Purpose
oral pain reliever
Uses
- For the temporary relief of pain due to toothache
- To help protect against infection of minor oral irritation.
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
- 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
- swelling, rash or fever develops • irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days • allergic reaction occurs
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
Stop use and ask a dentist or doctor if
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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
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
Inactive Ingredients:
Ammonium Glycyrrhizate, Flavor, PEG-400, PEG-3350, Sodium Saccharin Dihydrate, Sorbic Acid
Packaging
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