Finafta
FDA Label NDC 58593-780

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Efficient Laboratories Inc. for the product Finafta (NDC 58593-780). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, otc - questions, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients: (%)              Purpose

Ethyl Alcohol 60% v/v........................Anesthetic/Analgesic

Salicylic Acid 1% w/v.........................Anesthetic/Analgesic

Benzocaine USP 5% w/v...................Anesthetic/Analgesic

Otc - Purpose

Purpose

Anesthetic/Analgesic

Indications & Usage

Uses

For temporary relief of pain associated with canker sores

Warnings

Warnings

Methemoglobinemia warning: Use of this product may cause mthemoglobinemia, a serious condition that must be treated promptyly because it reduces the amount of oxygen carried in the 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 enegry

    • Allegry alert

    • do not use this product if you have a history of allergy to local anesthetics such as prcaine, butacaine, bezocaine, or other "caine" anesthetics.

      • Alcogol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whehter you should take slicylic acid or other pain reliever, fever reducer. Salicylic acid may cause stomach bleeding.

      Flammable: Keep away from fire or flame.

      Do not use

      • for teething
      • in children under 2 years of age

        • When using this prduct Do not use near eyes. Do not prolong usage unless directed by a doctor/dentist.

        Stop use and ask a doctor promptly if sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persists or worsens. If you sore throat is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose: Get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions

Adults and children over 12 years of age apply to the affected area, mouth, gums or mucous membrane with the applicator provided, up to 4 times daily or as directed by a dentist or doctor. Remain in place at least 1 minute and then spit out. Do not rinse mouth after each use. Children under 12 years of age should be supervised in the use of the product. Do not use in children under 2 years of age. 

Otc - Questions

Questions or comments?

305-805-3456

Monday-Friday (9 a.m. - 5 p.m. EST)

www.efficientlabs.com

Inactive Ingredient

Inactive Ingredients:

Propylene Glycol and Purified Water.

Package Label.Principal Display Panel

Finaftalabel (Finaftaadult)

Finaftalabel (Finaftaadult)

* Please review the disclaimer below.