70766-007

70766-007
SPL v2
SPL
SPL Set ID 0a491d55-03cc-4e26-aaf6-5e9c77d74fc5
Route
topical
Published
Effective Date 2022-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.1 g)
Inactive Ingredients
saccharin sodium sorbitol methylparaben sodium hydrated silica sodium lauryl sulfate propylparaben sodium water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-02-28
Purpose

anticavity

Description

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

Medication Information

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.

Uses

Help protect against dental cavities.

Purpose

anticavity

Directions

Adult and children six years of age or older:

  • Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician. 

Children 2-6:

  • Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing.

Children under 2:

  • Ask a dentist or physician
Description

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

Section 50565-1

Keep out of reach of children.

Section 51945-4

Active Ingredients

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

Inactive Ingredient

Sorbitol, Silica,Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Flavor, Water, SCMC, Sodium Lauryl Sulfate

Structured Label Content

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.

Uses

Help protect against dental cavities.

Purpose

anticavity

Directions

Adult and children six years of age or older:

  • Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physician. 

Children 2-6:

  • Use only a pea sized amount and supervise children's brushing and rinsing to minimize swallowing.

Children under 2:

  • Ask a dentist or physician
Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Active Ingredients (Active ingredients)

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

Inactive Ingredient (INACTIVE INGREDIENT)

Sorbitol, Silica,Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Flavor, Water, SCMC, Sodium Lauryl Sulfate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:27.837585 · Updated: 2026-03-14T23:02:00.533418