70766-014

70766-014
SPL v1
SPL
SPL Set ID 7daecf68-19b7-4c59-b9ed-565fb0967425
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 Xanthan Gum Glycerin Sodium Benzoate 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 2 years of age: consult 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

Sorbitol, Hydrated Silica, Glycerin, Water, PEG-400, Sodium Lauryl Sulfate, Cellulose Gum, Xanthan gum, flavor, Sodium Benzoate, Sodium sacharine

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 2 years of age: consult 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)

Sorbitol, Hydrated Silica, Glycerin, Water, PEG-400, Sodium Lauryl Sulfate, Cellulose Gum, Xanthan gum, flavor, Sodium Benzoate, Sodium sacharine

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:00.902076 · Updated: 2026-03-14T23:02:51.977564