Drug Facts - Red Cross Toothache

Drug Facts - Red Cross Toothache
SPL v10
SPL
SPL Set ID 3537e599-65d9-48d6-8a46-d42312f71e84
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eugenol (850 mg)
Inactive Ingredients
Sesame Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1983-06-21

Description

Eugenol 85%

Purpose

Toothache relief agent


Medication Information

Purpose

Toothache relief agent

Description

Eugenol 85%

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)

Questions

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

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 minute without 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

Active Ingredient

Eugenol 85%

Inactive Ingredients

sesame 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
Keep Out of Reach of Children

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

Package Label/principal Display Panel

Package Label Principal Display Panel

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.


Structured Label Content

Uses

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

Purpose

Toothache relief agent

Warnings

For external use only

Allergy alert: do not use if you are allergic to eugenol (clove oil)

Questions

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

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 minute without 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

Active Ingredient (Active ingredient)

Eugenol 85%

Inactive Ingredients

sesame oil

When Using This Product (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
Keep Out of Reach of Children

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

Package Label/principal Display Panel (Package Label/Principal Display Panel)

Package Label Principal Display Panel

Stop Use and Ask A Dentist Or Doctor If (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.


Advanced Ingredient Data


Raw Label Data

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