Label at a glance#

ProductDenTek Eugenol

Active ingredientEUGENOL

Label structure8 sections

Indications and uses

For the temporary relief of throbbing, persisitent toothache due to a cavity. Visit Dentist within 48 hours of use.

Dosage and administration

Directions Adults and children 12 year of age and older: Rinse the tooth with water to remove any food particles from the cavity. Moisten a cotton swab with Eugenol and place in the cavity for approximately 1 minute. Avoid touching tissue other than the tooth cavity. Apply the dose not more than four times daily or as directed by dentist or physician. Adults and children 12 years and older use up to 4 times daily ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Eugenol 85%

Purpose

OTC - PURPOSE SECTION

Toothache Relief Agent

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of throbbing, persisitent toothache due to a cavity. Visit Dentist within 48 hours of use.

Warnings

WARNINGS SECTION

Allergy alert: do not use if you are allergic to eugenol (clove oil).

When using this product

OTC - WHEN USING SECTION

use only in teeth with persistent throbbing pain
avoid touching tissuers other than tooth cavity
DO NOT SWALLOW to avoid irritation
avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

for more than 7 days
more than the recommended dosage.

Stop use and ask a dentist or doctor if

OTC - STOP USE SECTION

irritation persists
inflammation develops
if fever and infection develop.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children 12 year of age and older: Rinse the tooth with water to remove any food particles from the cavity. Moisten a cotton swab with Eugenol and place in the cavity for approximately 1 minute. Avoid touching tissue other than the tooth cavity. Apply the dose not more than four times daily or as directed by dentist or physician.

Adults and children 12 years and older use up to 4 times daily or as directed by a dentist or doctor.

Children under 12 years ask a dentist or doctor.

Inactive ingredient

INACTIVE INGREDIENT SECTION

sesame oil

Other information

OTHER SAFETY INFORMATION

Do not purchase if package has been opened
Store at 68-77 o F
Cap tightly to avoid evaporation.

DenTek Dental First Aid Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Entire label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
244327	eugenol 85 % Dental Solution	PSN	1
244327	eugenol 850 MG/ML Topical Solution	SCD	1
244327	eugenol 85 % Dental Solution	SY	1
244327	eugenol 85 % Topical Solution	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
EUGENOL 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
83062-400-21	2024-01-30	C162847	48780-1	1030e365-0773-111a-e063-dadaa90a10e2	DenTek Dental First Aid Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83062-400-20	DenTek Eugenol	3.5 mL in 1 VIAL, GLASS	LIQUID	3.5		1
83062-400-21	DenTek Eugenol	1 in 1 KIT	LIQUID	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83062-400	DENTEK EUGENOL (EUGENOL) LIQUID [IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.]	1	Legacy NDC, 2 package rows	20221022_eab5a54e-d02b-c5cb-e053-2995a90a7b21.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

DenTek Eugenol
Eugenol
SESAME OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
83062-400	83062-400-20, 83062-400-21
60630-566

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
EUGENOL	3T8H1794QW	ACTIB
SESAME OIL	QX10HYY4QV	IACT

Source Document#

Source XML

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
eab5a54e-d02c-c5cb-e053-2995a90a7b21			eab5a54e-d02b-c5cb-e053-2995a90a7b21	2022-10-10	Warnings	Exact identifier spl id: eab5a54e-d02c-c5cb-e053-2995a90a7b21 spl set id: eab5a54e-d02b-c5cb-e053-2995a90a7b21

Reported adverse events (FAERS/openFDA)#

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