SPL v1
SPL
SPL Set ID a9814859-fa3b-47f1-e053-2995a90ad465
Route
DENTAL
Published
Effective Date 2013-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.38 g)
Inactive Ingredients
Xylitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-07-01
Description

SODIUM MONOFLUOROPHOSPHATE

Medication Information

Warnings and Precautions

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

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

Indications and Usage

Supervise children as necessary until capable of using without Supervision.

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 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

For dental use only

Description

SODIUM MONOFLUOROPHOSPHATE

Section 50565-1

Keep out of reach of children

Section 51727-6

Sorbitol, Water, Hydrated Silica, Silica, Glycerin, Flavor, Sodium Citrate,

Cellulose Gum, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate,

Menthol, Charcoal Powder.,Carrageenan, Xanthan Gum, Sodium Saccharin,

Sodium Benzoate, Tocopheryl Acetate, Xylitol, Camellia Sinensis Leaf Extract,

Juglans Regia (Walnut) Shell Powder, Sodium Bicarbonate, Calendula Officinalis Extract, Chamomilla Recutita (Matricaria) Extract, Magnolia Officinalis Bark Extract

Section 51945-4

Section 55105-1

For dental care

Section 55106-9

SODIUM MONOFLUOROPHOSPHATE

Structured Label Content

Indications and Usage (34067-9)

Supervise children as necessary until capable of using without Supervision.

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 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)

For dental use only

Warnings and Precautions (34071-1)

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

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

Section 51727-6 (51727-6)

Sorbitol, Water, Hydrated Silica, Silica, Glycerin, Flavor, Sodium Citrate,

Cellulose Gum, Sodium Cocoyl Glutamate, Sodium Lauroyl Sarcosinate,

Menthol, Charcoal Powder.,Carrageenan, Xanthan Gum, Sodium Saccharin,

Sodium Benzoate, Tocopheryl Acetate, Xylitol, Camellia Sinensis Leaf Extract,

Juglans Regia (Walnut) Shell Powder, Sodium Bicarbonate, Calendula Officinalis Extract, Chamomilla Recutita (Matricaria) Extract, Magnolia Officinalis Bark Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For dental care

Section 55106-9 (55106-9)

SODIUM MONOFLUOROPHOSPHATE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:06.661840 · Updated: 2026-03-14T22:57:30.442086