Finafta

Manufacturer: Efficient Laboratories Inc.
Effective date: 2024-10-14
Label type: HUMAN OTC DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-06-01 00:25:15

Label at a glance#

ProductFinafta MultiOral

Active ingredientBENZOCAINE

Label structure10 sections

Contacts and useful links#

PhoneLabel contact305-805-3456

Websitewww.efficientlabs.com

www.efficientlabs.com

Label 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

FinaftaMulti

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1110820	benzocaine 75 MG/ML Mucosal Spray [Finafta Multi Oral]	benzocaine 75 MG/ML Mucosal Spray [Finafta Multi Oral]	SBD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1110816	benzocaine 7.5 % Mucosal Spray	PSN	12
1110820	Finafta Multi Oral 7.5 % Mucosal Spray	PSN	12
1110820	benzocaine 75 MG/ML Mucosal Spray [Finafta Multi Oral]	SBD	12
1110816	benzocaine 75 MG/ML Mucosal Spray	SCD	12
1110820	Finafta Multi Oral 7.5 % Mucosal Spray	SY	12
1110820	Finafta Multi Oral 75 MG/ML Mucosal Spray	SY	12

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58593-782-02	2020-02-19	C162847	48780-1	9d75b9d0-1cd2-f424-e053-dadaa90a57ce	28c5a993-fb5f-4091-af15-32ccae4b9a7d
58593-782-02	2020-01-31	C162847	48780-1	9d75b9d0-1cd2-f424-e053-dadaa90a57ce	28c5a993-fb5f-4091-af15-32ccae4b9a7d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58593-782-02	FinaftaMultiOral	59 mL in 1 BOTTLE, SPRAY	SPRAY	59		12
58593-782-02	FinaftaMultiOral	1 in 1 CARTON	SPRAY	1		12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58593-782	FINAFTA MULTIORAL (BENZOCAINE) SPRAY [EFFICIENT LABORATORIES INC.]	12	Current NDC, Legacy NDC, 2 package rows	20241016_28c5a993-fb5f-4091-af15-32ccae4b9a7d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	2
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	2
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Finafta MultiOral
Benzocaine
BENZALKONIUM CHLORIDE
METHYLPARABEN
PEPPERMINT OIL
PHOSPHORIC ACID
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58593-782	58593-782-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
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#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 196 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii+route 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii+route 40 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii+dosage form 38 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii+route 20 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii+route 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii+dosage form 44 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SUSPENSION / ORAL	100 mg/1ml		Exact identifier — unii+route 20 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii+route 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii+route 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii+route 38 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii+dosage form 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii+route 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii+dosage form 38 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii+route 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii+route 40 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii+route 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii+route 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii+route 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii+route 42 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / ORAL		346 mg	Exact identifier — unii+route 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii+route 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii+route 38 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii+route 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii+route 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii+route 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii+route 38 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii+route 40 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	SYRUP / ORAL		120 mg	Exact identifier — unii+route 20 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii+route 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii+route 38 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii+route 40 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / ORAL		19 mg	Exact identifier — unii+route 10 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii+route 38 equally ranked IID candidates
PEPPERMINT OIL	PEPPERMINT OIL	AV092KU4JH	TABLET / ORAL		28 mg	Exact identifier — unii+route 20 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET / ORAL	0.04 mg		Exact identifier — unii+route 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii+route 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii+route 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii+route 42 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii+route 40 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii+route 38 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii+dosage form 38 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii+dosage form 38 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii+route 10 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii+route 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii+route 42 equally ranked IID candidates
PHOSPHORIC ACID	PHOSPHORIC ACID	E4GA8884NN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii+route 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii+dosage form 40 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Finafta MultiOral	BENZOCAINE	Efficient Laboratories Inc.	28c5a993-fb5f-4091-af15-32ccae4b9a7d	2024-10-14	Warnings	Exact identifier ndc (package): 58593-782-02 ndc (product): 58593-782 ndc11 (package): 58593078202 spl id: 24702e3e-55f4-4231-e063-6394a90aebbe spl set id: 28c5a993-fb5f-4091-af15-32ccae4b9a7d

Reported adverse events (FAERS/openFDA)#

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