DENTEK EUGENOL- eugenol liquid 
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.

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.

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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.

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

DenTek Dental First Aid Kit

Entire label

DENTEK EUGENOL 
eugenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83062-400(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) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83062-400-211 in 1 KIT10/10/2022
1NDC:83062-400-203.5 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 finalpart35610/10/2022
Labeler - IIMED MEDICAL MEXICANA S. DE R.L. DE C.V. (812894376)
Establishment
NameAddressID/FEIBusiness Operations
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.812894376relabel(83062-400) , repack(83062-400)

Revised: 10/2022
Document Id: eab5a54e-d02c-c5cb-e053-2995a90a7b21
Set id: eab5a54e-d02b-c5cb-e053-2995a90a7b21
Version: 1
Effective Time: 20221010
 
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.