Anadent Kanka Gel
FDA Label NDC 27854-177

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Belmora Llc for the product Anadent Kanka Gel (NDC 27854-177). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

    • 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

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

Belmora-177 (2785417701)

Belmora-177 (2785417701)

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