Dentek Dental First Aid Kit

Dentek Dental First Aid Kit
SPL v1
SPL
SPL Set ID eab5a54e-d02b-c5cb-e053-2995a90a7b21
Route
DENTAL
Published
Effective Date 2022-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eugenol (850 mg)
Inactive Ingredients
Sesame Oil

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-10-10

Description

Eugenol 85%

Purpose

Toothache Relief Agent


Medication Information

Purpose

Toothache Relief Agent

Description

Eugenol 85%

Uses

For the temporary relief of throbbing, persisitent toothache due to a cavity. Visit Dentist within 48 hours of use.

Warnings

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

Directions

Directions Adults and children 12 year of age and older: Rinse the tooth with water to remove any food particles from the cavity. Moisten a cotton swab with Eugenol and place in the cavity for approximately 1 minute. Avoid touching tissue other than the tooth cavity. Apply the dose not more than four times daily or as directed by 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.

Do Not Use
  • for more than 7 days
  • more than the recommended dosage.
Active Ingredient

Eugenol 85%

Other Information
  • Do not purchase if package has been opened
  • Store at 68-77 o F
  • Cap tightly to avoid evaporation.
Inactive Ingredient

sesame oil

When Using This Product
  • use only in teeth with persistent throbbing pain
  • avoid touching tissuers other than tooth cavity
  • DO NOT SWALLOW to avoid irritation
  • avoid contact with eyes.
Dentek Dental First Aid Kit

Keep Out of Reach of Children

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

Stop Use and Ask A Dentist Or Doctor If
  • irritation persists
  • inflammation develops
  • if fever and infection develop.

Structured Label Content

Uses

For the temporary relief of throbbing, persisitent toothache due to a cavity. Visit Dentist within 48 hours of use.

Purpose

Toothache Relief Agent

Warnings

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

Directions

Directions Adults and children 12 year of age and older: Rinse the tooth with water to remove any food particles from the cavity. Moisten a cotton swab with Eugenol and place in the cavity for approximately 1 minute. Avoid touching tissue other than the tooth cavity. Apply the dose not more than four times daily or as directed by 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.

Do Not Use (Do not use)
  • for more than 7 days
  • more than the recommended dosage.
Active Ingredient (Active ingredient)

Eugenol 85%

Other Information (Other information)
  • Do not purchase if package has been opened
  • Store at 68-77 o F
  • Cap tightly to avoid evaporation.
Inactive Ingredient (Inactive ingredient)

sesame oil

When Using This Product (When using this product)
  • use only in teeth with persistent throbbing pain
  • avoid touching tissuers other than tooth cavity
  • DO NOT SWALLOW to avoid irritation
  • avoid contact with eyes.
Dentek Dental First Aid Kit (DenTek Dental First Aid Kit)

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.

Stop Use and Ask A Dentist Or Doctor If (Stop use and ask a dentist or doctor if)
  • irritation persists
  • inflammation develops
  • if fever and infection develop.

Advanced Ingredient Data


Raw Label Data

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