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#
Contacts and useful links#
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
INACTIVE INGREDIENT SECTION
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GLYCERIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58593-783-15 | Finafta | 15 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 15 | 7 |
Products#
Every source-derived product name is available through these pages.
- Finafta
- Benzocaine, Glycerin
- PROPYLPARABEN
- POLYETHYLENE GLYCOL 1000
- PHOSPHORIC ACID
- BENZOCAINE
- MENTHOL
- SUCRALOSE
- METHYLPARABEN
- PROPYLENE GLYCOL
- WATER
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58593-783 | 58593-783-15 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| POLYETHYLENE GLYCOL 1000 | U076Q6Q621 | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| MENTHOL | L7T10EIP3A | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 6 | 2024-10-14 | full-release | 2026-06-01 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Finafta | BENZOCAINE, GLYCERIN | Efficient Laboratories Inc. | 03368603-3e11-c2fa-e063-6294a90a04ea | 2025-10-14 | Warnings | 58593-783-15 58593-783 58593078315 411e9f10-dd14-5800-e063-6294a90afb4b 03368603-3e11-c2fa-e063-6294a90a04ea |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
