Anadent

Anadent
SPL v2
SPL
SPL Set ID 9c06211c-f05a-4ce7-89e5-63a63efb7f96
Route
DENTAL
Published
Effective Date 2022-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eugenol (12 mg)
Inactive Ingredients
Ammonium Glycyrrhizate Polyethylene Glycol 400 Polyethylene Glycol 3350 Saccharin Sodium Sorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-08

Description

Eugenol 1.2%

Purpose

Toothache Relief Agent


Medication Information

Purpose

Toothache Relief Agent

Description

Eugenol 1.2%

Uses:

For the temporary relief of throbbing, persistent toothache.

Section 42229-5

PAIN RELIEF

For toothaches

Distributed by Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201

www.anadentusa.com

Section 50565-1

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

Section 53413-1

Questions/Comments please call: 1 888 779 2877 Monday to Friday 9AM - 5PM EST

Packaging

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

• DO NOT SWALLOW to avoid irritation  • avoid contact with eyes

Do not use

• for more than 7 days  • more than the recommended dose

Stop use and ask a dentist or doctor if

• irritation persists  • inflammation develops  • fever and infection develop

Directions

• Adults and children 2 to 12 years of age and older: Moisten a cotton pellet with 1 or 2 drops of the product and then apply to the cotton pellet on the applicable tooth. 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.

Drug Facts

Active Ingredient

Eugenol 1.2%

Other Information

• Do not purchase if package has been opened  • Store at 46 - 90°F

• Cap tightly to avoid evaporation

Inactive Ingredients:

Ammonium Glycyrrhizate, Flavor, PEG-400, PEG-3350, Sodium Saccharin Dihydrate, Sorbic Acid


Structured Label Content

Uses:

For the temporary relief of throbbing, persistent toothache.

Section 42229-5 (42229-5)

PAIN RELIEF

For toothaches

Distributed by Belmora LLC, 3033 Wilson Blvd. Suite 700 Arlington, VA 22201

www.anadentusa.com

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 53413-1 (53413-1)

Questions/Comments please call: 1 888 779 2877 Monday to Friday 9AM - 5PM EST

Purpose

Toothache Relief Agent

Packaging

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

• DO NOT SWALLOW to avoid irritation  • avoid contact with eyes

Do not use

• for more than 7 days  • more than the recommended dose

Stop use and ask a dentist or doctor if

• irritation persists  • inflammation develops  • fever and infection develop

Directions

• Adults and children 2 to 12 years of age and older: Moisten a cotton pellet with 1 or 2 drops of the product and then apply to the cotton pellet on the applicable tooth. 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.

Drug Facts

Active Ingredient

Eugenol 1.2%

Other Information

• Do not purchase if package has been opened  • Store at 46 - 90°F

• Cap tightly to avoid evaporation

Inactive Ingredients:

Ammonium Glycyrrhizate, Flavor, PEG-400, PEG-3350, Sodium Saccharin Dihydrate, Sorbic Acid


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)