DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.22 g)

Inactive Ingredients

Sodium Lauryl Sulfate Xanthan Gum Saccharin Sodium Sorbitol Sodium Benzoate Water Silicon Dioxide Carboxymethylcellulose Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-11

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

Sodium Fluoride 0.22%

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, Carboxymethyl cellulose Sodium, Saccharin sodium,Sodium benzoate, Sorbitol, Sodium lauryl sulfate,Flavor,Silicon Dioxide, Xanthan gum

Section 51945-4

ZONSEN NDC: 72932-015-00

Oral Care

Gel 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 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, Carboxymethyl cellulose Sodium, Saccharin sodium,Sodium benzoate, Sorbitol, Sodium lauryl sulfate,Flavor,Silicon Dioxide, Xanthan gum

Section 51945-4 (51945-4)

ZONSEN NDC: 72932-015-00

Oral Care

Gel 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

[{"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.22", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Aids in the prevention of dental cavities.", "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.", "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.", "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.", "51727-6": "Water, Carboxymethyl cellulose Sodium, Saccharin sodium,Sodium benzoate, Sorbitol, Sodium lauryl sulfate,Flavor,Silicon Dioxide, Xanthan gum", "51945-4": "ZONSEN NDC: 72932-015-00 Oral Care Gel Fluoride Toothpaste FRESH MINT FLAVOR 0.6 OZ. (17 g)", "55105-1": "Anticavity", "55106-9": "Sodium Fluoride 0.22%"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information