Dentek Dental First Aid Kit

Dentek Dental First Aid Kit
SPL v3
SPL
SPL Set ID 3afcd2bf-94fb-11c9-e054-00144ff8d46c
Route
DENTAL
Published
Effective Date 2015-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eugenol (150 mg)
Inactive Ingredients
Sesame Oil

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-07-01

Description

Active Ingredient Eugenol 85%


Medication Information

Warnings and Precautions

Warnings

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

Indications and Usage

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

Dosage and Administration

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.

Description

Active Ingredient Eugenol 85%

Section 50565-1

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

Section 50566-9

Stop use and ask a dentist or doctor if: . irritation persists . inflammation develops . if fever and infection develop.

Section 50567-7

When using this product: . use only in teeth with persistent, throbbing pain . avoid touching tissuers othere than tooth cavity . DO NOT

SWALLOW to avoid irritation . avoid contact with eyes.

Section 50570-1

Do not use: . for more than 7 days . more than the recommended dosage.

Section 51727-6

Inactive ingredient: sesame oil

Section 55105-1

Purpose Toothache Relief Agent

Section 55106-9

Active Ingredient Eugenol 85%

Section 60561-8

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

Outer Retail Package Label Dentek Dental First Aid Kit


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a dentist or doctor if: . irritation persists . inflammation develops . if fever and infection develop.

Section 50567-7 (50567-7)

When using this product: . use only in teeth with persistent, throbbing pain . avoid touching tissuers othere than tooth cavity . DO NOT

SWALLOW to avoid irritation . avoid contact with eyes.

Section 50570-1 (50570-1)

Do not use: . for more than 7 days . more than the recommended dosage.

Section 51727-6 (51727-6)

Inactive ingredient: sesame oil

Section 55105-1 (55105-1)

Purpose Toothache Relief Agent

Section 55106-9 (55106-9)

Active Ingredient Eugenol 85%

Section 60561-8 (60561-8)

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

Outer Retail Package Label Dentek Dental First Aid Kit (Outer Retail Package Label - DenTek Dental First Aid Kit)


Advanced Ingredient Data


Raw Label Data

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