EUGENOL TOOTHACHE MEDICATION- eugenol liquid

Eugenol Toothache Medication by

Drug Labeling and Warnings

Eugenol Toothache Medication by is a Otc medication manufactured, distributed, or labeled by Team Technologies, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Eugenol 85%

PURPOSE

Purpose Toothache Relief Agent

INDICATIONS & USAGE

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

WARNINGS

Warnings

For external use only. Allergy alert: do not use if you are allergic to eugenol (clove oil).

WHEN USING

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

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

STOP USE

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

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.

DOSAGE & ADMINISTRATION

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 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.

INACTIVE INGREDIENT

Inactive ingredient sesame oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EUGENOL TOOTHACHE MEDICATION 
eugenol liquid

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)