Otc - Active Ingredient
Active Ingredients: (%) Purpose
Benzocaine USP 5%..................Oral Anesthetic
Glycerin 33% .........................Oral Demulcen
Finafta Liquid
FDA Label NDC 58593-783
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 58593-783). 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 - Purpose
Purpose
Oral Anesthetic
Oral Demulcen
Indications & Usage
Uses
For temporary relief of pain associated with canker sores
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
- do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.
Allergy alert
Do not use this 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.
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 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.
Otc - Questions
Questions or comments?
305-805-3456
Monday-Friday (9 a.m. - 5 p.m. EST)
www.efficientlabs.com
Inactive Ingredient
Inactive Ingredients:
menthol, methylparaben, polyethylene glycol, propylparaben, propylene glycol, purified water, phosphoric acid, sucralose.
Other Information
• finafta is tolerable to iodine-sensitive individuals.
• store between 15° - 30°C (59° - 86°F).
• close bottle tightly after each use.
• Keep box for information.
Tamper-Evident:do not accept if safety seal is broken or missing.
* Please review the disclaimer below.
