77573-012

77573-012
SPL v2
SPL
SPL Set ID fa04010f-6c5c-4921-a1f7-e1770e9aef12
Route
TOPICAL
Published
Effective Date 2022-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 g)
Inactive Ingredients
Saccharin Sodium Sorbitol Glycerin Hydrated Silica Sodium Lauryl Sulfate Calcium Carbonate Water Methylparaben Sodium Propylparaben Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-07-10
Description

Sodium Fluoride 0.22%(0.1 w/v Fluoride Ion)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.22%(0.1 w/v Fluoride Ion)

Uses

Help protect against 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 more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.

Directions
  • Adults and children 6 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 a physician.
  • Children 2 to 6 years: Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing
  • Children under 2 years: Ask a dentist or physician
Active Ingredients

Sodium Fluoride 0.22%(0.1 w/v Fluoride Ion)

Inactive Ingredient

Sorbitol, Silica, Calcium Carbonate, Methylparaben Sodium, Propylparaben Sodium, Flavor, Sodium Saccharin, Water,  SCMC, Sodium Lauryl Sulfate

Structured Label Content

Uses

Help protect against 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 more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.

Directions
  • Adults and children 6 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 a physician.
  • Children 2 to 6 years: Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing
  • Children under 2 years: Ask a dentist or physician
Active Ingredients (Active ingredients)

Sodium Fluoride 0.22%(0.1 w/v Fluoride Ion)

Inactive Ingredient (INACTIVE INGREDIENT)

Sorbitol, Silica, Calcium Carbonate, Methylparaben Sodium, Propylparaben Sodium, Flavor, Sodium Saccharin, Water,  SCMC, Sodium Lauryl Sulfate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:39.822347 · Updated: 2026-03-14T23:02:20.876891