SPL v4
SPL
SPL Set ID f6af454c-e43a-4f3a-a6f2-c58a2f0fdb4e
Route
DENTAL
Published
Effective Date 2016-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.208 g)
Inactive Ingredients
Sorbitol Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Titanium Dioxide Saccharin Sodium Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2015-04-01
Description

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Medication Information

Warnings and Precautions

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 doctor.

Instruct children under 6 years of age in good brushing ad rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Children under 2 years of age

Consult a dentist or doctor

Description

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Section 50565-1

Keep out of reach of children under 6 years of age

Section 51727-6

Sodium carboxymethylcellulose, Sodium lauryl sulfate, Sodium saccharin, Sorbitol, Titanium dioxide, Tocopheryl acetate, water

Section 51945-4

Section 55105-1

Purpose Anticavity

Section 55106-9

Sodium monofluorophosphate 0.75% (0.13% 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 doctor.

Instruct children under 6 years of age in good brushing ad rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Children under 2 years of age

Consult a dentist or doctor

Warnings and Precautions (34071-1)

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 under 6 years of age

Section 51727-6 (51727-6)

Sodium carboxymethylcellulose, Sodium lauryl sulfate, Sodium saccharin, Sorbitol, Titanium dioxide, Tocopheryl acetate, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose Anticavity

Section 55106-9 (55106-9)

Sodium monofluorophosphate 0.75% (0.13% w/v Fluoride ion)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:08.618632 · Updated: 2026-03-14T22:54:23.335310