SPL v7
SPL
SPL Set ID 1a42cf2d-6c48-4e38-97bc-b6f2084bf39b
Route
DENTAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.43 mg)
Inactive Ingredients
Sorbitol Silicon Dioxide Water Glycerin Polyethylene Glycol 1600 Sodium Lauryl Sulfate Titanium Dioxide Carboxymethylcellulose Sodium, Unspecified Carrageenan Sodium Phosphate, Tribasic, Dodecahydrate Sodium Saccharin Sodium Benzoate Sodium Pyrophosphate Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-04-04
Description

Sodium Fluoride - 0.243% (0.15 w/v fluoride ion)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium Fluoride - 0.243% (0.15 w/v fluoride ion)

Uses

Aids in the prevention of dental cavities

Section 51945-4

Warnings

Keep out of reach of children under 6 years of age.if you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years & older:

  • Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
  • Do not swallow.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing, use a pea-sized amount)
  • Supervise children's brushing until good habits are established.

Children under 2 years:

  • Consult a dentist or doctor
Otc Purpose

Anticavity

Inactive Ingredients

Sorbitol, Silica, Treated Water, Glycerin, PEG-32, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Phosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, FD&C Blue #1

Otc Active Ingredient

Sodium Fluoride - 0.243% (0.15 w/v fluoride ion)

Keep Out of Reach of Children Under 6 Years of Age

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Structured Label Content

Uses

Aids in the prevention of dental cavities

Section 51945-4 (51945-4)

Warnings

Keep out of reach of children under 6 years of age.if you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years & older:

  • Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
  • Do not swallow.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing, use a pea-sized amount)
  • Supervise children's brushing until good habits are established.

Children under 2 years:

  • Consult a dentist or doctor
Otc Purpose (OTC Purpose)

Anticavity

Inactive Ingredients

Sorbitol, Silica, Treated Water, Glycerin, PEG-32, Sodium Lauryl Sulfate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Phosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, FD&C Blue #1

Otc Active Ingredient (OTC Active Ingredient)

Sodium Fluoride - 0.243% (0.15 w/v fluoride ion)

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

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:25.842994 · Updated: 2026-03-14T23:10:51.714911