Eugenol by Polysciences, Inc Eugenol

Eugenol by

Drug Labeling and Warnings

Eugenol by is a Otc medication manufactured, distributed, or labeled by Polysciences, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EUGENOL- eugenol liquid 
Polysciences, 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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Eugenol

Active ingredients:

Eugenol 85%

Purpose

Toothache Relief Agent

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses:

For the temporary relief of throbbing, persistent toothache due to 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 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.

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.
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

sesame oil

Questions or comments? 1-888-811-6188

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2012 Walgreen Co.
MADE IN U.S.A
0712-250608A ORG1112-GF

Packaging

image description

EUGENOL 
eugenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61291-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL850 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SESAME OIL (UNII: QX10HYY4QV)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61291-011-043.7 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product01/30/201512/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/30/201512/12/2019
Labeler - Polysciences, Inc (014249635)
Establishment
NameAddressID/FEIBusiness Operations
Polysciences, Inc014249635manufacture(61291-011)

Revised: 12/2019
 
Polysciences, Inc