![WALGREENS NATURAL EUGENOL/TOOTHACHE MEDICATION WITH COTTON PELLETS AND TWEEZERS (EUGENOL) LIQUID [TEAM TECHNOLOGIES, INC]](https://medic.hrt.org//dailymed/images/3afd5a15-02d3-27d3-e054-00144ff88e88/Walgreens-Toothache_111815.jpg)
| NDC | 67659-405-21, 67659-405-23 |
| Set ID | 3afd5a15-02d3-27d3-e054-00144ff88e88 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Team Technologies, Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART356 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
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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
- QUESTIONS
- Outer package card labeling
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INGREDIENTS AND APPEARANCE
WALGREENS NATURAL EUGENOL/TOOTHACHE MEDICATION WITH COTTON PELLETS AND TWEEZERS
eugenol liquidProduct 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)
