Dawnmist Toothpaste

SPL v6

SPL

SPL Set ID 460c0f54-367a-4300-b066-5071d718ea73

Route

ORAL

Published

Effective Date 2018-08-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.22 g)

Inactive Ingredients

Calcium Carbonate Water Sorbitol Sodium Lauryl Sulfate Silicon Dioxide Carboxymethylcellulose Potassium Nitrate Sodium Benzoate Saccharin Sodium Menthol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2013-11-13 Until 2026-07-31

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 pea sized amount and supervise brushing until good habits are established.

Children under 2 years: Ask a doctor or physician.

Expiration Date

Expiration date & batch No. on crimp of tube

Warnings Section

Warnings

Active Ingredient

Sodium fluoride 0.22%

Inactive Ingredients

calcium carbonate,water,sorbitol, sodium lauryl sulfate, silica, carboxymethyl cellulose, flavor, potassium nitrate, sodium benzoate, sodium saccharin, menthol

Keep Out of Reach of Children

Keep out of reach of children under six years of age. If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control Center immediately

Principal Display Panel Dawnmist Fluoride Toothpaste 0.6 Oz Tube Label

DawnMist ^®

NDC: 65517-2000-0

ORAL CARE

Fluoride Toothpaste

CAVITY FIGHTING FORMULA

FRESH MINT FLAVOR

0.6 OZ. (17 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 pea sized amount and supervise brushing until good habits are established.

Children under 2 years: Ask a doctor or physician.

Expiration Date (Expiration date)

Expiration date & batch No. on crimp of tube

Warnings Section

Warnings

Active Ingredient (Active ingredient)

Sodium fluoride 0.22%

Inactive Ingredients (Inactive ingredients)

calcium carbonate,water,sorbitol, sodium lauryl sulfate, silica, carboxymethyl cellulose, flavor, potassium nitrate, sodium benzoate, sodium saccharin, menthol

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children under six years of age. If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control Center immediately

Principal Display Panel Dawnmist Fluoride Toothpaste 0.6 Oz Tube Label (Principal Display Panel - DawnMist Fluoride Toothpaste 0.6 OZ Tube Label)

DawnMist ^®

NDC: 65517-2000-0

ORAL CARE

Fluoride Toothpaste

CAVITY FIGHTING FORMULA

FRESH MINT FLAVOR

0.6 OZ. (17 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 pea sized amount and supervise brushing until good habits are established. Children under 2 years: Ask a doctor or physician.", "Expiration date": "Expiration date & batch No. on crimp of tube", "Warnings Section": "Warnings", "Active ingredient": "Sodium fluoride 0.22%", "Inactive ingredients": "calcium carbonate,water,sorbitol, sodium lauryl sulfate, silica, carboxymethyl cellulose, flavor, potassium nitrate, sodium benzoate, sodium saccharin, menthol", "Keep out of reach of children": "Keep out of reach of children under six years of age. If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control Center immediately", "Principal Display Panel - DawnMist Fluoride Toothpaste 0.6 OZ Tube Label": "DawnMist ® NDC: 65517-2000-0 ORAL CARE Fluoride Toothpaste CAVITY FIGHTING FORMULA FRESH MINT FLAVOR 0.6 OZ. (17 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:15.270258 · Updated: 2026-03-14T23:03:14.317302