DENTEK EUGENOL- eugenol liquid 
DenTek Oral Care, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.


DenTek Dental First Aid Kit

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.


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 othere 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 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.

Outer Retail Package Label - DenTek Dental First Aid Kit

front and back of card

eugenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60630-566
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL850 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SESAME OIL (UNII: QX10HYY4QV) 150 mg  in 1 mL
Product Characteristics
Coloryellow (Clear to pale yellow liquid, with odor of cloves) Score    
FlavorImprint Code
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60630-566-021 in 1 KIT07/01/2015
1NDC:60630-566-013.7 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/2015
Labeler - DenTek Oral Care, Inc. (153818646)
Registrant - DenTek Oral Care, Inc. (153818646)
NameAddressID/FEIBusiness Operations
Polysciences, Inc.014249635manufacture(60630-566)
NameAddressID/FEIBusiness Operations
DenTek Oral Care, Inc.153818646label(60630-566)

Revised: 12/2015
Document Id: 27f82004-adec-1112-e054-00144ff8d46c
Set id: 27f82004-adeb-1112-e054-00144ff8d46c
Version: 1
Effective Time: 20151228
DenTek Oral Care, Inc.