65517-2004 - Dawnmist Gel Fluoride Toothpaste

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.22 g)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-05-01

Medication Information

Warnings and Precautions

Keep out of the reach of children under 6 years of age.

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

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

Section 51945-4

DawnMist

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2004-1

Dukal

0.6oz (17g)

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.

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)

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

Section 51945-4 (51945-4)

DawnMist

Gel Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2004-1

Dukal

0.6oz (17g)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium Fluoride 0.22%

Advanced Ingredient Data

[{"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.22", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "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.", "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": "Carboxymethylcellulose Sodium, Flavor, Saccharin Sodium, Silicon Dioxide, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol, Water, Xanthan Gum", "51945-4": "DawnMist Gel Fluoride Toothpaste FRESH MINT FLAVOR NDC: 65517-2004-1 Dukal 0.6oz (17g)", "55105-1": "Anticavity", "55106-9": "Sodium Fluoride 0.22%"}

65517-2004 - Dawnmist Gel Fluoride Toothpaste

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information