70766-015 Dawnmist

70766-015 Dawnmist
SPL v1
SPL
SPL Set ID 6c72752d-eafa-4418-9d0e-aa41a6ba0bde
Route
DENTAL
Published
Effective Date 2024-04-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 g)
Inactive Ingredients
Water Sorbitol Hydrated Silica Sodium Lauryl Sulfate Methylparaben Propylparaben Calcium Carbonate Hydroxypropyl Guar (2500-4500 Mpa.s At 1%) Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-04
Description

SODIUM FLUORIDE   0.22%(0.10 w/v Fluoride ion) <text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/> </text></text></text></text></text>

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

SODIUM FLUORIDE   0.22%(0.10 w/v Fluoride ion) <text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/><text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)</paragraph> <paragraph/> </text></text></text></text></text>

Uses

Aids in the prevention of dental cavities.

Section 50565-1

Keep out of reach of children.

Section 51945-4

Warnings

Keep out of the reach of children under 6 years of age. If you accidently swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

Directions
  • 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 minimizing swallowing). 
  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a doctor.
  • Children under 6 years of age: Do not use unless directed by a doctor or dentist.
Active Ingredients

SODIUM FLUORIDE   0.22%(0.10 w/v Fluoride ion)

<text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/>&lt;text xmlns="urn:hl7-org:v3"> &lt;paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)&lt;/paragraph> &lt;paragraph/>&amp;lt;text xmlns="urn:hl7-org:v3"> &amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;lt;/paragraph> &amp;lt;paragraph/>&amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;lt;/paragraph> &amp;amp;lt;paragraph/>&amp;amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;amp;lt;/paragraph> &amp;amp;amp;lt;paragraph/> &amp;amp;amp;lt;/text>&amp;amp;lt;/text>&amp;lt;/text>&lt;/text></text>

Inactive Ingredient

Calcium Carbonate, Water, Sorbitol, PEG-400, Sodium Lauryl Sulfate, Hydrated Silica, Cellulose Gum, Flavor, Hydroxypropyl Guar, , Sodium Sacharine, Methylparaben, Propylparaben

Structured Label Content

Uses

Aids in the prevention of dental cavities.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Purpose

Anticavity

Warnings

Keep out of the reach of children under 6 years of age. If you accidently swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

Directions
  • 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 minimizing swallowing). 
  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a doctor.
  • Children under 6 years of age: Do not use unless directed by a doctor or dentist.
Active Ingredients (Active ingredients)

SODIUM FLUORIDE   0.22%(0.10 w/v Fluoride ion)

<text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/>&lt;text xmlns="urn:hl7-org:v3"> &lt;paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)&lt;/paragraph> &lt;paragraph/>&amp;lt;text xmlns="urn:hl7-org:v3"> &amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;lt;/paragraph> &amp;lt;paragraph/>&amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;lt;/paragraph> &amp;amp;lt;paragraph/>&amp;amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;amp;lt;/paragraph> &amp;amp;amp;lt;paragraph/> &amp;amp;amp;lt;/text>&amp;amp;lt;/text>&amp;lt;/text>&lt;/text></text>

Inactive Ingredient (INACTIVE INGREDIENT)

Calcium Carbonate, Water, Sorbitol, PEG-400, Sodium Lauryl Sulfate, Hydrated Silica, Cellulose Gum, Flavor, Hydroxypropyl Guar, , Sodium Sacharine, Methylparaben, Propylparaben

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:00.899592 · Updated: 2026-03-14T23:02:51.977564