Therabreath™

Therabreath™
SPL v1
SPL
SPL Set ID 19ce5324-7d8d-4d70-ad9b-238f7e612eac
Route
ORAL
Published
Effective Date 2024-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-08

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Uses

Aids in the prevention of dental decay.

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

Do not swallow.

Supervise children as necessary until capable of using without supervision.

Adults and children 6 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 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by 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, Hydrated Silica, Glycerin, Xylitol, Natural Flavors, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Ammonium Glycyrrhizate, Sodium Benzoate, Citric Acid, Sodium Chlorite, Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C).

Principal Display Panel 113.5 G Tube Carton

DENTIST FORMULATED

FIGHTS CAVITIES

FIGHTS BAD BREATH FOR 12H*

ANTICAVITY FLUORIDE TOOTHPASTE

TheraBreath

DENTIST FORMULATED

FRESH BREATH

TOOTHPASTE

FIGHTS CAVITIES

FIGHTS BAD BREATH FOR 12 HOURS*

AntiCavity

With Aloe Vera

Net Wt. 4 oz. • 113.5 g

MILD MINT

Read back panel for current directions

FIGHTS BAD BREATH FOR 12 HOURS*


Structured Label Content

Uses

Aids in the prevention of dental decay.

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

Directions

Do not swallow.

Supervise children as necessary until capable of using without supervision.

Adults and children 6 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 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by 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, Hydrated Silica, Glycerin, Xylitol, Natural Flavors, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Ammonium Glycyrrhizate, Sodium Benzoate, Citric Acid, Sodium Chlorite, Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C).

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

DENTIST FORMULATED

FIGHTS CAVITIES

FIGHTS BAD BREATH FOR 12H*

ANTICAVITY FLUORIDE TOOTHPASTE

TheraBreath

DENTIST FORMULATED

FRESH BREATH

TOOTHPASTE

FIGHTS CAVITIES

FIGHTS BAD BREATH FOR 12 HOURS*

AntiCavity

With Aloe Vera

Net Wt. 4 oz. • 113.5 g

MILD MINT

Read back panel for current directions

FIGHTS BAD BREATH FOR 12 HOURS*


Advanced Ingredient Data


Raw Label Data

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