Finafta 5 mg/100mL
Benzocaine, Glycerin · LIQUID · Efficient Laboratories Inc.
Finafta is a liquid containing benzocaine, glycerin at 5 mg/100mL, taken topical. Manufactured by Efficient Laboratories Inc..
Key Facts
- Brand Name
- Finafta
- Generic Name
- Benzocaine, Glycerin
- NDC Code (Product)
58593-783- Manufacturer
- Efficient Laboratories Inc.
- Strength
- 5 mg/100mL
- Dosage Form
- LIQUID
- Route
- TOPICAL
- Marketing Status
- Application #
- M022
- Drug Class
- Standardized Chemical Allergen [EPC]; Non-Standardized Chemical Allergen [EPC]
- Marketing Start
- 09/15/2023
Recall History
Product Quest Manufacturing LLC
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses For temporary relief of pain associated with canker sores
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 between 2 and 12 years of age: consult a doctor •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.
Warnings
Warnings Do not exceed recommended dosage 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 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 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 t his product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
Frequently Asked Questions
What is Finafta used for?
Finafta contains Benzocaine, Glycerin. It is a liquid taken topical. Consult your doctor for specific uses.
Is Finafta a controlled substance?
Finafta is not classified as a controlled substance by the DEA.
What is the generic name for Finafta?
The generic name for Finafta is Benzocaine, Glycerin. There are 1 other brand versions of Benzocaine, Glycerin.
What is the NDC code for Finafta 5 mg/100mL?
The NDC (National Drug Code) for Finafta 5 mg/100mL is 58593-783, listed by Efficient Laboratories Inc..