Finafta
- Manufacturer
- Dextrum Laboratories Inc.
- Effective date
- 2025-09-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:14:37
Label at a glance#
ProductFinafta MultiOral
Active ingredientBENZOCAINE
Label structure10 sections
Contacts and useful links#
Websitewww.efficientlabs.com
www.efficientlabs.com
www.efficientlabs.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: (%) Purpose
Benzocaine USP 7.5% ................ Oral Anesthetic/Analgesic
OTC - PURPOSE SECTION
Purpose
Oral Anesthetic/Analgesic
WARNINGS SECTION
Warnings: Do not exceed recommended dosage
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.
Do not use
- for teething
- in children under 2 years of age
Consult a doctor promptly if:
sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens. If sore throat is sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting.
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding, ask a health professional before use.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS:
For children over 12 years of age and Adults
• Apply Finafta® MultiOral Spray up to 4 times daily to affected areas of the mouth, gums or mucus membranes (mouth and throat).
- Allow to remain in place at least 1 minute and then spit out.
• Close bottle tightly after each use.
- Children under 12 years of age: Do not use.
INDICATIONS & USAGE SECTION
USES
For the temporary relief of occasional minor irritation, pain, sore mouth, pain associated with canker sores or pain due to minor irritation of the mouth and gums cause by dentures or othodontic applicances.
INACTIVE INGREDIENT SECTION
Inactive ingredients:
Benzalkonium chloride, glycerin, methylparaben, peppermint oil, phosphoric acid, propylene glycol, propylparaben and purified water.
OTC - QUESTIONS SECTION
QUESTIONS OR COMMENTS?
305-805-3456
Monday-Friday (9 a.m.- 5 p.m. EST)
www.efficientlabs.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1110816 | benzocaine 7.5 % Mucosal Spray | PSN | 1 |
| 1110820 | Finafta Multi Oral 7.5 % Mucosal Spray | PSN | 1 |
| 1110820 | benzocaine 75 MG/ML Mucosal Spray [Finafta Multi Oral] | SBD | 1 |
| 1110816 | benzocaine 75 MG/ML Mucosal Spray | SCD | 1 |
| 1110820 | Finafta Multi Oral 7.5 % Mucosal Spray | SY | 1 |
| 1110820 | Finafta Multi Oral 75 MG/ML Mucosal Spray | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65852-001-02 | FinaftaMultiOral | 1 in 1 CARTON | SPRAY | 1 | 1 | |
| 65852-001-02 | FinaftaMultiOral | 59 mL in 1 BOTTLE, SPRAY | SPRAY | 59 | 1 |
Products#
Every source-derived product name is available through these pages.
- Finafta MultiOral
- Benzocaine
- BENZALKONIUM CHLORIDE
- METHYLPARABEN
- PEPPERMINT OIL
- PHOSPHORIC ACID
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 65852-001 | 65852-001-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
Source Document#
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 MultiOral | BENZOCAINE | Dextrum Laboratories Inc. | cb027ab8-4175-4cc0-a73e-991dfb113df9 | 2025-09-23 | Warnings | 65852-001-02 65852-001 65852000102 3f7c6100-fd2d-9cd9-e063-6294a90a2486 cb027ab8-4175-4cc0-a73e-991dfb113df9 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.