Therabreath ®

Therabreath ®
SPL v2
SPL
SPL Set ID a4dba786-df60-4b4f-85d9-636e275664af
Route
DENTAL
Published
Effective Date 2024-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.24 g)
Inactive Ingredients
Sorbitol Hydrated Silica Glycerin Xylitol Carboxymethylcellulose Sodium, Unspecified Potassium Pyrophosphate Sodium Pyrophosphate Sodium Benzoate Aloe Vera Leaf Citric Acid Monohydrate Sodium Chlorite Zinc Gluconate Ammonium Glycyrrhizate Ascorbic Acid Ubidecarenone Mentha Arvensis Leaf Oil Spearmint Oil Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2024-01-01 Until 2026-03-18

Description

Drug Facts

Purpose

Anticavity Fluoride Dentifrice


Medication Information

Purpose

Anticavity Fluoride Dentifrice

Description

Drug Facts

Uses

Aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults & Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Other Information
  • If spilled on fabrics, wash out immediately.
  • This product was sealed with protective packaging at the laboratory.
  • If seal is missing, do not use.
Active Ingredients

Sodium fluoride 0.24% (0.14% W/V fluoride ion)

Inactive Ingredients

Sorbitol, Water (Aqua), Hydrated Silica, Glycerin (from vegetable sources), Xylitol, Natural Flavor, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Sodium Benzoate, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Chlorite, Zinc Gluconate, Ammonium Glycyrrhizate, Ascorbic Acid (Vitamin C), Ubiquinone (COQ10), Mentha Arvensis (Cornmint) Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Natural Fragrance (Parfum)

Principal Display Panel 113.5 G Tube Label

ANTICAVITY TOOTHPASTE

CLINICAL FORMULA

TheraBreath ®

PLUS

MAXIMUM STRENGTH

FRESH BREATH

TOOTHPASTE

FRESHENS BREATH FOR 24 HOURS*

Fortified with Zinc, Xylitol and Aloe

Nothing Works Faster and Lasts Longer

to Prevent Bad Breath

Dr. Harold Katz

net wt. 4 oz. • 113.5 g

PEPPERMINT


Structured Label Content

Uses

Aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity Fluoride Dentifrice

Directions

Adults & Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Other Information (Other information)
  • If spilled on fabrics, wash out immediately.
  • This product was sealed with protective packaging at the laboratory.
  • If seal is missing, do not use.
Active Ingredients

Sodium fluoride 0.24% (0.14% W/V fluoride ion)

Inactive Ingredients

Sorbitol, Water (Aqua), Hydrated Silica, Glycerin (from vegetable sources), Xylitol, Natural Flavor, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Sodium Benzoate, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Chlorite, Zinc Gluconate, Ammonium Glycyrrhizate, Ascorbic Acid (Vitamin C), Ubiquinone (COQ10), Mentha Arvensis (Cornmint) Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Natural Fragrance (Parfum)

Principal Display Panel 113.5 G Tube Label (PRINCIPAL DISPLAY PANEL - 113.5 g Tube Label)

ANTICAVITY TOOTHPASTE

CLINICAL FORMULA

TheraBreath ®

PLUS

MAXIMUM STRENGTH

FRESH BREATH

TOOTHPASTE

FRESHENS BREATH FOR 24 HOURS*

Fortified with Zinc, Xylitol and Aloe

Nothing Works Faster and Lasts Longer

to Prevent Bad Breath

Dr. Harold Katz

net wt. 4 oz. • 113.5 g

PEPPERMINT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)