WALGREENS NATURAL EUGENOL/TOOTHACHE MEDICATION WITH COTTON PELLETS AND TWEEZERS- eugenol liquid

Walgreens Natural Eugenol/Toothache Medication by

Drug Labeling and Warnings

Walgreens Natural Eugenol/Toothache Medication by is a Otc medication manufactured, distributed, or labeled by Team Technologies, Inc, Team Technolgies, 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 this product:

. use only in teeth with pesistent, throbbing pain

. avoid touching tissues other than tooth cavity

. DO NOT SWALLOW to avoid irritation

. do not use for more than 7 days

. do not exceed recommended dosage

Stop use and ask a dentist or doctor if irritation persists, inflammation develops, or if 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 12 years of age and older Rinse the tooth with water to remove any food particles from the cavity.

Moisten a cotton pellet with 1 to 2 drops of Eugenol and 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 under 12 years ask a dentist or doctor.

INACTIVE INGREDIENT

Inactive Ingredient: sesame oil

QUESTIONS

Questions or comments? 1-888-811-6188

Outer package card labeling

INGREDIENTS AND APPEARANCE

WALGREENS NATURAL EUGENOL/TOOTHACHE MEDICATION  WITH COTTON PELLETS AND TWEEZERS
eugenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67659-405(NDC:60630-608)
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 (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: 67659-405-21	1 in 1 KIT	07/01/2015
1	NDC: 67659-405-23	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 Technolgies, Inc		079527756	repack(67659-405) , relabel(67659-405)