SPL v2
SPL
SPL Set ID b4942b2c-5480-3302-e053-2995a90a9bb7
Route
DENTAL
Published
Effective Date 2020-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Water Stevia Rebaudiana Whole Xanthan Gum Coconut Oil Xylitol Hydrated Silica Glycerin Carboxymethylcellulose Sodium (0.7 Carboxymethyl Substitution Per Saccharide; 1200 Mpa.s At 1%) Sodium Cocoyl Glutamate Green Tea Leaf Menthol Sorbitol Spearmint Oil Activated Charcoal Cannabis Sativa Seed Oil Centella Asiatica Scutellaria Baicalensis Root Calendula Officinalis Flower Glycyrrhiza Glabra Matricaria Recutita

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-11-20
Description

Sodium Monofluorophosphate 0.76%

Medication Information

Warnings and Precautions

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

Indications and Usage

Directions:

Adult 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

Children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years: ask a dentist or physician.

Dosage and Administration

Paste pea size of toothpaste on the tooth brush

Description

Sodium Monofluorophosphate 0.76%

Use

Helps protect against cavities

Section 50565-1

Keep out of reach of children under 6 years of age.

Section 51727-6

Sorbitol, purified water, Hydrated silica, Glycerin, Xylitol, Xanthan gum, Sodium Cocoyl Glutamate, Stevia Rebaudiana Extract, Cocos Nucifera (Coconut) Oil, Cellulose Gum, Menthol, Mentha Spicata Herb Oil, Rosmarinus Offiicinalis (Rosemary) Extract, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Calendula Officinalis Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Extract, Charcoal Powder, Cannabis Sativa (Hemp) Seed Oil

Section 51945-4

250g; NDC 81111-100-01

Section 55106-9

Sodium Monofluorophosphate 0.76%

Structured Label Content

Use

Helps protect against cavities

Indications and Usage (34067-9)

Directions:

Adult 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

Children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years: ask a dentist or physician.

Dosage and Administration (34068-7)

Paste pea size of toothpaste on the tooth brush

Warnings and Precautions (34071-1)

If more than used for brushing is accidentally swalloed, 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)

Sorbitol, purified water, Hydrated silica, Glycerin, Xylitol, Xanthan gum, Sodium Cocoyl Glutamate, Stevia Rebaudiana Extract, Cocos Nucifera (Coconut) Oil, Cellulose Gum, Menthol, Mentha Spicata Herb Oil, Rosmarinus Offiicinalis (Rosemary) Extract, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Calendula Officinalis Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Extract, Charcoal Powder, Cannabis Sativa (Hemp) Seed Oil

Section 51945-4 (51945-4)

250g; NDC 81111-100-01

Section 55106-9 (55106-9)

Sodium Monofluorophosphate 0.76%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:07.928892 · Updated: 2026-03-14T23:00:28.895348