Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 2fa21cac-e71e-4bda-93ac-b5672d2d5095
Route
DENTAL
Published
Effective Date 2024-11-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.2 mg)
Inactive Ingredients
Water Sorbitol Carbomer Homopolymer Type C Sodium Lauryl Sulfate Polyethylene Glycol 1600 Saccharin Sodium Silicon Dioxide Carboxymethylcellulose Sodium Sodium Hydroxide Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-09-17
Description

Sodium Fluoride - 0.22%  (0.1% w/v fluoride ion)

Medication Information

Warnings and Precautions

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

aids in the prevention of dental cavities

Dosage and Administration

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

  • 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 as necessary until capable of using without supervision

Children under 2 years: Ask a dentist or doctor

Description

Sodium Fluoride - 0.22%  (0.1% w/v fluoride ion)

Section 50565-1

Keep out of reach of children.  If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Treated Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Flavor, PEG-32, Sodium Saccharin, Silica, Cellulose Gum, Sodium Hydroxide, Disodium EDTA

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9

Sodium Fluoride - 0.22%  (0.1% w/v fluoride ion)

Structured Label Content

Indications and Usage (34067-9)

aids in the prevention of dental cavities

Dosage and Administration (34068-7)

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

  • 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 as necessary until capable of using without supervision

Children under 2 years: Ask a dentist or doctor

Warnings and Precautions (34071-1)

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.  If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Treated Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Flavor, PEG-32, Sodium Saccharin, Silica, Cellulose Gum, Sodium Hydroxide, Disodium EDTA

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium Fluoride - 0.22%  (0.1% w/v fluoride ion)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:19.209356 · Updated: 2026-03-14T23:04:56.462927