65517-2005 - Dawnmist Fluoride Toothpaste

65517-2005 - Dawnmist Fluoride Toothpaste
SPL v3
SPL
SPL Set ID 147f7738-5080-9907-e063-6294a90a6170
Route
DENTAL
Published
Effective Date 2025-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-25

Description

DawnMist Fluoride Toothpaste


Medication Information

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

DawnMist Fluoride Toothpaste

Section 42229-5

DawnMist 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

Calcium Carbonate, Carboxymethylcellulose Sodium, Flavor, Guaraprolose, Saccharin Sodium, Silicon Dioxide, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol, Water

Section 51945-4

DawnMist

Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2005-0

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.

Section 42229-5 (42229-5)

DawnMist 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)

Calcium Carbonate, Carboxymethylcellulose Sodium, Flavor, Guaraprolose, Saccharin Sodium, Silicon Dioxide, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbitol, Water

Section 51945-4 (51945-4)

DawnMist

Fluoride Toothpaste

FRESH MINT FLAVOR

NDC: 65517-2005-0

Dukal

0.6oz (17g)

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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