EUGENOL TOOTHACHE MEDICATION- eugenol liquid 
Team Technologies, 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.

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CVS TOOTHACHE RELIEF & REPAIR KIT

Active Ingredient Eugenol 85%

Purpose Toothache Relief Agent

Uses For the temporary relief of throbbing, persistent toothache due to a cavity. Visit Dentist within 48 hours of use.

Warnings

For external use only. 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 . DO NOT SWALLOW to avoid irritation . avoid contact with eyes

Do not use. For more than 7 days . more than the recommended dose

Stop use and ask a dentist or doctor if. irritation persists . inflammation develops . 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 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.

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.

Inactive ingredient sesame oil

kit package label

EUGENOL TOOTHACHE MEDICATION 
eugenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67659-415(NDC:60630-686)
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 (colorless to pale yellow liquid, with odor of cloves) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67659-415-211 in 1 KIT07/01/2015
1NDC:67659-415-233.7 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 - Team Technologies, Inc (192339703)
Registrant - Team Technologies, Inc (192339703)
Establishment
NameAddressID/FEIBusiness Operations
Team Technologies, Inc079527756repack(67659-415) , relabel(67659-415)

Revised: 8/2016
Document Id: 3afd5a15-02ef-27d3-e054-00144ff88e88
Set id: 3afd5a15-02ee-27d3-e054-00144ff88e88
Version: 1
Effective Time: 20160826
 
Team Technologies, Inc