Label: EUGENOL TOOTHACHE MEDICATION- eugenol liquid
- NDC Code(s): 67659-415-21, 67659-415-23
- Packager: Team Technologies, Inc
- This is a repackaged label.
- Source NDC Code(s): 60630-686
- 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, persistent toothache due to a cavity. Visit Dentist within 48 hours of use.Close
For external use only. 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 . DO NOT SWALLOW to avoid irritation . avoid contact with eyesClose
- DO NOT USE
Do not use. For more than 7 days . more than the recommended doseClose
- STOP USE
Stop use and ask a dentist or doctor if. irritation persists . inflammation develops . fever and infection developClose
- 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
Adults and children 2 to 12 years of age and older: Rinse tooth with water to remove any food particles from the cavity. Moisten a cotton pellet with 1 or 2 drops of medication and using the tweezer, place in the cavity for approximately 1 minute. Avoid touching tissues other than the tooth cavity . Apply the dose not more than four times daily or as directed by a dentist or physician.
Children 2 to 12 years of age: should be supervised in the use of this product.
Children under 2 years of age: use only under the advice of a dentist or physician.Close
- OTHER SAFETY INFORMATION
Other information. Do not purchase if package has been opened. . Store at 46 - 90 o F. . Cap tightly to avoid evaporation. . toothaches and open cavities indicate serious problems which need prompt attention by a dentist.Close
- INACTIVE INGREDIENT
Inactive ingredient sesame oilClose
- INGREDIENTS AND APPEARANCE
EUGENOL TOOTHACHE MEDICATION
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67659-415(NDC:60630-686) 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 (colorless 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:67659-415-21 1 in 1 KIT 07/01/2015 1 NDC:67659-415-23 3.7 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 repack(67659-415) , relabel(67659-415)