SPL v2
SPL
SPL Set ID 3baca3b6-ff48-0579-e063-6394a90abd08
Route
DENTAL
Published
Effective Date 2025-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Tetrasodium Pyrophosphate Cocamidopropyl Betaine Fragrance 13576 Xanthan Gum Titanium Dioxide Hydroxyapatite Hydrated Silica Sodium Lauroyl Sarcosinate 1,3-beta-glucan Synthase Component Fks1 Cellulose Gum Water Dicalcium Phosphate Glycerin Citric Acid Sodium Benzoate Sorbitol Sodium Saccharin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-06

Description

Sodium monofluorophosphate 0.76% (0.76g/100g)


Medication Information

Warnings and Precautions

Keep out of 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

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 and 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.

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 and rinsing habits (to minimize swallowing).

Description

Sodium monofluorophosphate 0.76% (0.76g/100g)

Section 50565-1

Keep out of reach of children under 6 years of age

Section 51727-6

Sorbitol, Water, Hydrated Silica, Dicalcium Phosphate, Hydroxyapatite, Glycerin, Cocamidopropyl Betaine, Sodium Lauroyl Sarcosinate, Fragrance, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Tetrasodium Pyrophosphate, Titanium Dioxide, Sodium Saccharin, Citric Acid, Beta-Glucan

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9

Sodium monofluorophosphate 0.76% (0.76g/100g)


Structured Label Content

Indications and Usage (34067-9)

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 and 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.

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 and rinsing habits (to minimize swallowing).

Warnings and Precautions (34071-1)

Keep out of 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 under 6 years of age

Section 51727-6 (51727-6)

Sorbitol, Water, Hydrated Silica, Dicalcium Phosphate, Hydroxyapatite, Glycerin, Cocamidopropyl Betaine, Sodium Lauroyl Sarcosinate, Fragrance, Cellulose Gum, Xanthan Gum, Sodium Benzoate, Tetrasodium Pyrophosphate, Titanium Dioxide, Sodium Saccharin, Citric Acid, Beta-Glucan

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium monofluorophosphate 0.76% (0.76g/100g)


Advanced Ingredient Data


Raw Label Data

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