Cvs Toothache Relief & Repair Kit (prestige)

Cvs Toothache Relief & Repair Kit (prestige)
SPL v2
SPL
SPL Set ID 3afd5a15-02ee-27d3-e054-00144ff88e88
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

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

Indications and Usage

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

Dosage and Administration

Directions

Adults and children 2 to 12 years of age and older: Rinse tooth with water to remove any food particles from the cavity. Moisten a cotton pellet with 1 or 2 drops of medication and using the tweezer, 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.

Children 2 to 12 years of age: should be supervised in the use of this product.

Children under 2 years of age: use only under the advice of a dentist or physician.

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 . fever and infection develop

Section 50567-7

When using this product:

. use only in teeth with persistent throbbing pain . 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 dose

Section 51727-6

Inactive ingredient sesame oil

Section 51945-4

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 46 - 90 o F. . Cap tightly to avoid evaporation. . toothaches and open cavities indicate serious problems which need prompt attention by a dentist.


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions

Adults and children 2 to 12 years of age and older: Rinse tooth with water to remove any food particles from the cavity. Moisten a cotton pellet with 1 or 2 drops of medication and using the tweezer, 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.

Children 2 to 12 years of age: should be supervised in the use of this product.

Children under 2 years of age: use only under the advice of a dentist or physician.

Warnings and Precautions (34071-1)

Warnings

For external use only. 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 . fever and infection develop

Section 50567-7 (50567-7)

When using this product:

. use only in teeth with persistent throbbing pain . 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 dose

Section 51727-6 (51727-6)

Inactive ingredient sesame oil

Section 51945-4 (51945-4)

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 46 - 90 o F. . Cap tightly to avoid evaporation. . toothaches and open cavities indicate serious problems which need prompt attention by a dentist.


Advanced Ingredient Data


Raw Label Data

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