WALGREENS NATURAL EUGENOL/TOOTHACHE MEDICATION WITH COTTON PELLETS AND TWEEZERS- eugenol liquid 
DenTek Oral Care, 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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Walgreens Complete Toothache Kit, with Eugenol, cotton pellets and tweezers.

Outer package card labeling

Labeling for complete 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 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. If swallowed, get medical help or contact a Poison Control Center right away.

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: sesame oil

Questions or comments? 1-888-811-6188

WALGREENS NATURAL EUGENOL/TOOTHACHE MEDICATION  WITH COTTON PELLETS AND TWEEZERS
eugenol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) 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:60630-608-02 1 in 1 PACKAGE 07/01/2015
1 NDC:60630-608-01 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 - DenTek Oral Care, Inc. (153818646)
Registrant - DenTek Oral Care, Inc. (153818646)

Revised: 12/2015
Document Id: 25eb9c24-1fa8-100f-e054-00144ff88e88
Set id: 25eb9c24-1fa7-100f-e054-00144ff88e88
Version: 2
Effective Time: 20151202
 
DenTek Oral Care, Inc.