Finafta

Manufacturer
Efficient Laboratories Inc.
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:38:52

Label at a glance#

ProductFinafta
Active ingredientBENZOCAINE, GLYCERIN
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: (%) Purpose

Benzocaine USP 5%..................Oral Anesthetic

Glycerin 33% .........................Oral Demulcen

OTC - PURPOSE SECTION

Purpose

Oral Anesthetic

Oral Demulcen

INDICATIONS & USAGE SECTION

Uses

For temporary relief of pain associated with canker sores

WARNINGS SECTION

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 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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Questions or comments?

305-805-3456

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

www.efficientlabs.com

INACTIVE INGREDIENT SECTION

Inactive Ingredients:


menthol, methylparaben, polyethylene glycol, propylparaben, propylene glycol, purified water, phosphoric acid, sucralose.

Other Information

OTHER SAFETY 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58593-783-15Finafta15 mL in 1 BOTTLE, WITH APPLICATORLIQUID157

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58593-78358593-783-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-10-14full-release2026-06-01 00:25:00

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
ndc (package): 58593-783-15
ndc (product): 58593-783
ndc11 (package): 58593078315
spl id: 411e9f10-dd14-5800-e063-6294a90afb4b
spl set id: 03368603-3e11-c2fa-e063-6294a90a04ea

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.