Label at a glance#

ProductDenTek Eugenol

Active ingredientEUGENOL

Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Eugenol 85%

OTC - PURPOSE SECTION

Purpose Toothache Relief Agent

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

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

OTC - WHEN USING SECTION

When using this product:. use only in teeth with persistent, throbbing pain . avoid touching tissuers othere than tooth cavity . DO NOT

SWALLOW to avoid irritation . avoid contact with eyes.

OTC - DO NOT USE SECTION

Do not use: . for more than 7 days . more than the recommended dosage.

OTC - STOP USE SECTION

Stop use and ask a dentist or doctor if: . irritation persists . inflammation develops . if fever and infection develop.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 SECTION

Inactive ingredient: sesame oil

OTHER SAFETY INFORMATION

Other information Do not purchase if package has been opened. Store at 68-77 ^oF. Cap tightly to avoid evaporation.

Outer Retail Package Label - DenTek Dental First Aid Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

front and back of card

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
244327	eugenol 85 % Dental Solution	PSN	3
244327	eugenol 850 MG/ML Topical Solution	SCD	3
244327	eugenol 85 % Dental Solution	SY	3
244327	eugenol 85 % Topical Solution	SY	3

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
67659-400-21	2024-01-30	C162847	48780-1	9d75b9d0-4c0f-f424-e053-dadaa90a57ce	DenTek Dental First Aid Kit
67659-400-21	2022-07-31	C162847	48780-1	9d75b9d0-4c0f-f424-e053-dadaa90a57ce	DenTek Dental First Aid Kit
67659-400-21	2020-01-31	C162847	48780-1	9d75b9d0-4c0f-f424-e053-dadaa90a57ce	DenTek Dental First Aid Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67659-400-20	DenTek Eugenol	3.5 mL in 1 VIAL, GLASS	LIQUID	3.5		3
67659-400-21	DenTek Eugenol	1 in 1 KIT	LIQUID	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67659-400	DENTEK EUGENOL (EUGENOL) LIQUID [TEAM TECHNOLOGIES, INC]	3	Legacy NDC, 2 package rows	20220802_3afcd2bf-94fb-11c9-e054-00144ff8d46c.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
67659-400	67659-400-20, 67659-400-21
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
SESAME OIL	QX10HYY4QV	IACT
EUGENOL	3T8H1794QW	ACTIB

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
e4f87bd3-2593-5603-e053-2a95a90a5e6e			3afcd2bf-94fb-11c9-e054-00144ff8d46c	2022-07-29	Warnings	Exact identifier spl id: e4f87bd3-2593-5603-e053-2a95a90a5e6e spl set id: 3afcd2bf-94fb-11c9-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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