Label: DENTEK EUGENOL- eugenol liquid
- NDC Code(s): 83062-400-20, 83062-400-21
- Packager: IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.
- This is a repackaged label.
- Source NDC Code(s): 60630-566
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated October 10, 2022
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- Active ingredient
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.
Stop use and ask a dentist or doctor if
- irritation persists
- inflammation develops
- if fever and infection develop.
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
- Other information
- DenTek Dental First Aid Kit
INGREDIENTS AND APPEARANCE
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)