DENTEK EUGENOL- eugenol liquid

DenTek Eugenol by

Drug Labeling and Warnings

DenTek Eugenol by is a Otc medication manufactured, distributed, or labeled by IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Eugenol 85%

Purpose

Toothache Relief Agent

Uses

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

Warnings

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

When using this product

• 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

• for more than 7 days
• more than the recommended dosage.

Stop use and ask a dentist or doctor if

• irritation persists
• inflammation develops
• if fever and infection develop.

Keep out of reach of children

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

Directions

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

sesame oil

Other 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

INGREDIENTS AND APPEARANCE

DENTEK EUGENOL 
eugenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83062-400(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)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83062-400-21	1 in 1 KIT	10/10/2022
1	NDC: 83062-400-20	3.5 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	10/10/2022

Labeler - IIMED MEDICAL MEXICANA S. DE R.L. DE C.V. (812894376)

Establishment
Name	Address	ID/FEI	Business Operations
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.		812894376	relabel(83062-400) , repack(83062-400)