SPL v2
SPL
SPL Set ID 2c3349bf-710b-fb84-e063-6394a90a3cc7
Route
DENTAL
Published
Effective Date 2025-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.22 g)
Inactive Ingredients
Sodium Lauryl Sulfate Silicon Dioxide Sodium Benzoate Sorbitol Carboxymethylcellulose Sodium Guaraprolose (1300 Mpa.s At 1%) Saccharin Sodium Calcium Carbonate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-11

Description

ZONSEN Fluoride Toothpaste


Medication Information

Warnings and Precautions

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

Indications and Usage

Aids in the prevention of dental cavities.

Dosage and Administration

Do not swallow, supervise children as necessary until capable of using without supervision. Instruct Children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). 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. Children under 6 years of age: Do not use unless directed by a doctor or dentist.

Description

ZONSEN Fluoride Toothpaste

Section 42229-5

ZONSEN Fluoride Toothpaste

Section 50565-1

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

Section 51727-6

Water, Calcium carbonate, Silicon Dioxide, Carboxymethyl cellulose Sodium,Guaraprolose, Saccharin sodium, Sodium benzoate, Sorbitol, Sodium lauryl sulfate, flavor

Section 51945-4

ZONSEN NDC:72932-016-00

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

0.6 OZ. (17 g)

Section 55105-1

Anticavity

Section 55106-9

Sodium Fluoride 0.22%


Structured Label Content

Indications and Usage (34067-9)

Aids in the prevention of dental cavities.

Dosage and Administration (34068-7)

Do not swallow, supervise children as necessary until capable of using without supervision. Instruct Children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). 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. Children under 6 years of age: Do not use unless directed by a doctor or dentist.

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

ZONSEN Fluoride Toothpaste

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Water, Calcium carbonate, Silicon Dioxide, Carboxymethyl cellulose Sodium,Guaraprolose, Saccharin sodium, Sodium benzoate, Sorbitol, Sodium lauryl sulfate, flavor

Section 51945-4 (51945-4)

ZONSEN NDC:72932-016-00

Oral Care

Fluoride Toothpaste

FRESH MINT FLAVOR

0.6 OZ. (17 g)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium Fluoride 0.22%


Advanced Ingredient Data


Raw Label Data

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