Label: DENTEK EUGENOL- eugenol liquid
- NDC Code(s): 67659-400-20, 67659-400-21
- Packager: Team Technologies, Inc
- 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 August 26, 2016
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- ACTIVE INGREDIENT
Active Ingredient Eugenol 85%Close
Purpose Toothache Relief AgentClose
- INDICATIONS & USAGE
Uses For the temporary relief of throbbing, persisitent toothache due to a cavity. Visit Dentist within 48 hours of use.Close
Allergy alert: do not use if you are allergic to eugenol (clove oil).Close
- 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.Close
- DO NOT USE
Do not use: . for more than 7 days . more than the recommended dosage.Close
- STOP USE
Stop use and ask a dentist or doctor if: . irritation persists . inflammation develops . if fever and infection develop.Close
- 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.Close
- 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.Close
- INACTIVE INGREDIENT
Inactive ingredient: sesame oilClose
- OTHER SAFETY INFORMATION
Other information Do not purchase if package has been opened. Store at 68-77 o F. Cap tightly to avoid evaporation.Close
- Outer Retail Package Label - DenTek Dental First Aid Kit
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67659-400(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 of cloves) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67659-400-21 1 in 1 KIT 07/01/2015 1 NDC:67659-400-20 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 07/01/2015 Labeler - Team Technologies, Inc (192339703) Registrant - Team Technologies, Inc (192339703) Establishment Name Address ID/FEI Business Operations Team Technologies, Inc 079527756 relabel(67659-400) , repack(67659-400)