DENTEK EUGENOL- eugenol liquid

DenTek Eugenol by

Drug Labeling and Warnings

DenTek Eugenol by is a Otc medication manufactured, distributed, or labeled by DenTek Oral Care, Inc., Polysciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Eugenol 85%

PURPOSE

Purpose Toothache Relief Agent

INDICATIONS & USAGE

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

WARNINGS

Warnings

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

WHEN USING

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.

DO NOT USE

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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 or as directed by a dentist or doctor.

Children under 12 years ask a dentist or doctor.

INACTIVE INGREDIENT

Inactive ingredient: sesame oil

OTHER SAFETY INFORMATION

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

Outer Retail Package Label - DenTek Dental First Aid Kit

INGREDIENTS AND APPEARANCE

DENTEK EUGENOL 
eugenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60630-566
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW)	EUGENOL	850 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SESAME OIL (UNII: QX10HYY4QV)	150 mg  in 1 mL

Product Characteristics
Color	yellow (Clear to pale yellow liquid, with odor of cloves)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60630-566-02	1 in 1 KIT	07/01/2015
1	NDC: 60630-566-01	3.7 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/01/2015

Labeler - DenTek Oral Care, Inc. (153818646)

Registrant - DenTek Oral Care, Inc. (153818646)

Establishment
Name	Address	ID/FEI	Business Operations
Polysciences, Inc.		014249635	manufacture(60630-566)

Establishment
Name	Address	ID/FEI	Business Operations
DenTek Oral Care, Inc.		153818646	label(60630-566)