RED CROSS TOOTHACHE- eugenol liquid 
The Mentholatum Company

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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Drug Facts

Active ingredient

Eugenol 85%

Purpose

Toothache relief agent

Uses

temporarily relieves throbbing, persistent toothache due to a cavity until a dentist can be seen

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. Contact with lips or mucous membranes can cause burning, swelling, or irritation.
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

See a dentist as soon as possible whether or not the pain is relieved. Toothaches and open cavities indicate serious problems that need prompt attention by a dentist.

Keep Out of Reach of Children

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

Directions

rinse tooth with water to remove any food particles from the cavity
using tweezers, immerse cotton pellet in medication
to prevent dripping, squeeze gently between fingers to remove excess liquid
place pellet in tooth cavity for one minutewithout touching surrounding tissues, then remove
supervise children using this product

adults and children 12 years and over: use up to 4 times daily or as directed by a dentist or doctor

children under 12 years: ask a dentist or doctor

Inactive Ingredients

sesame oil

Questions

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Package/Label Principal Display Panel

Red Cross Toothache

Principal Display Panel

Drug Facts
RED CROSS TOOTHACHE 
eugenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-0009
Route of AdministrationTOPICAL
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-0009-11 in 1 BLISTER PACK06/21/1983
13.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/21/1983
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757MANUFACTURE(10742-0009)

Revised: 1/2020
Document Id: f646efb3-678b-40a2-80b0-a48ddc467f32
Set id: 3537e599-65d9-48d6-8a46-d42312f71e84
Version: 7
Effective Time: 20200113
 
The Mentholatum Company