Dawnmist Gel Fluoride Toothpaste

SPL v5

SPL

SPL Set ID 3cd621bd-15aa-4c81-8734-91ccc929b4d6

Route

DENTAL

Published

Effective Date 2018-08-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.22 g)

Inactive Ingredients

Water Sorbitol Silicon Dioxide Sodium Lauryl Sulfate Polyethylene Glycol 1500 Carboxymethylcellulose Sodium Benzoate Saccharin Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2014-01-17 Until 2026-07-25

Description

Sodium Fluoride 0.22%

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.22%

Use

Aids in the prevention of dental cavities

Directions

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

Children under 6 years: To minimize swallowing, use a peas sized amount and supervisor brushing until good habits are established.

Children under 2 years: Ask a dentist or physician

Active Ingredient

Sodium Fluoride 0.22%

Inactive Ingredient

Sorbitol, Water, Silica, Sodium Lauryl Sulphate, PEG1500, Flavor, Carboxymethyl Cellulose, Sodium Benzoate, Sodium Saccharin

Dawnmist Gel Fluoride Toothpaste

Keep Out of Reach of Children Under 6 Years of Age

If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control immediately

Principal Display Panel Dawnmist Gel Fluoride Toothpaste 2.75 Oz Tube Label

DawnMist ^®

NDC: 65517-2017-0

ORAL CARE

Gel Fluoride Toothpaste

CAVITY FIGHTING FORMULA

FRESH MINT FLAVOR

2.75 OZ. (78 g)

Structured Label Content

Use

Aids in the prevention of dental cavities

Purpose

Anticavity

Directions

Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

Children under 6 years: To minimize swallowing, use a peas sized amount and supervisor brushing until good habits are established.

Children under 2 years: Ask a dentist or physician

Active Ingredient

Sodium Fluoride 0.22%

Inactive Ingredient

Sorbitol, Water, Silica, Sodium Lauryl Sulphate, PEG1500, Flavor, Carboxymethyl Cellulose, Sodium Benzoate, Sodium Saccharin

Dawnmist Gel Fluoride Toothpaste (DawnMist Gel Fluoride Toothpaste)

Keep Out of Reach of Children Under 6 Years of Age (Keep out of reach of children under 6 years of age)

If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control immediately

Principal Display Panel Dawnmist Gel Fluoride Toothpaste 2.75 Oz Tube Label (Principal Display Panel - DawnMist Gel Fluoride Toothpaste 2.75 oz Tube Label)

DawnMist ^®

NDC: 65517-2017-0

ORAL CARE

Gel Fluoride Toothpaste

CAVITY FIGHTING FORMULA

FRESH MINT FLAVOR

2.75 OZ. (78 g)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "Aids in the prevention of dental cavities", "Purpose": "Anticavity", "Directions": "Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children under 6 years: To minimize swallowing, use a peas sized amount and supervisor brushing until good habits are established. Children under 2 years: Ask a dentist or physician", "Active Ingredient": "Sodium Fluoride 0.22%", "Inactive Ingredient": "Sorbitol, Water, Silica, Sodium Lauryl Sulphate, PEG1500, Flavor, Carboxymethyl Cellulose, Sodium Benzoate, Sodium Saccharin", "Keep out of reach of children under 6 years of age": "If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control immediately", "Principal Display Panel - DawnMist Gel Fluoride Toothpaste 2.75 oz Tube Label": "DawnMist ® NDC: 65517-2017-0 ORAL CARE Gel Fluoride Toothpaste CAVITY FIGHTING FORMULA FRESH MINT FLAVOR 2.75 OZ. (78 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:15.269085 · Updated: 2026-03-14T23:03:14.317302