Label: EUGENOL- eugenol liquid
- NDC Code(s): 61291-011-04
- Packager: Polysciences, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 17, 2014
If you are a consumer or patient please visit this version.
- Active ingredients:
Toothache Relief AgentClose
- 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.Close
For the temporary relief of throbbing, persistent toothache due to cavity. Visit Dentist within 48 hours of use.Close
Warnings For external use only. Allergy alert: do not use if you are allergic to eugenol (clove oil).Close
When using this product:
• use only in teeth with persistent, 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.
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.Close
Adults and children 12 years and older use up to 4 times daily or as directed by a dentist or doctor.
Children under 12 years ask a dentist or doctor.
- Inactive ingredient
Questions or comments? 1-888-811-6188Close
- SPL UNCLASSIFIED SECTION
DISTRIBUTED BY: WALGREEN CO.Close
200 WILMOT RD., DEERFIELD, IL 60015
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walgreens.com ©2012 Walgreen Co.
MADE IN U.S.A
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61291-011 Route of Administration ORAL 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) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61291-011-04 3.7 mL in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/30/2015 Labeler - Polysciences, Inc (014249635) Establishment Name Address ID/FEI Business Operations Polysciences, Inc 014249635 manufacture(61291-011)