SPL v1
SPL
SPL Set ID 0c556a29-a697-3a66-e063-6394a90abfee
Route
TOPICAL
Published
Effective Date 2022-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.24 g)
Inactive Ingredients
Magnesium Chloride Sodium Polymetaphosphate Citric Acid Monohydrate Sodium Acid Pyrophosphate Titanium Dioxide Myrciaria Dubia Fruit Water Sodium Benzoate Mica Sodium Gluconate Sorbitol Sodium Coco-sulfate Mentha Arvensis Leaf Oil Sodium Sulfate Sodium Cocoyl Glutamate Sucralose Coconut Oil Sea Salt Peppermint Oil Alcohol Green Tea Leaf Stevia Rebaudiuna Leaf Carvone, (+/-)- Methyl Salicylate Echinacea Angustifolia Leaf Asian Ginseng Hydrated Silica Glycerin Carboxymethylcellulose Sodium, Unspecified Carrageenan Vanillin Cranberry Seed Oil Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-01
Description

Directions: Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. To minimize swallowing use a pea-sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 years ask a dentist.

Medication Information

Warnings and Precautions

Contains sodium fluoride. Children of 6 years and younger: Use a pea-sized amount with supervised brushin to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

Indications and Usage

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing.

Dosage and Administration

Directions:

Adults and children 2 years and older:

Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.

Do not swallow. To minimize swallowing use a pea-sized amount in children under 6.

Supervise children's brushing until good habits are established.

Children under 2 years ask a dentist.

Description

Directions: Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. To minimize swallowing use a pea-sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 years ask a dentist.

Section 50565-1

Keep out of reach of children under 6 years of age. If more than used for brushin is accidentally swallowed, get medical help or contact a Poison Control Center right away. Children of 6 years and younger: Use a pea-sized amount with supervised brushin to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

Section 51727-6

Hydrated Silica, Glycerin, Water, Sorbitol, Sodium Cocoyl Glutamate, Sodium Coco-Sulfate, Sodium Benzoate, MenthaArvensis Leaf Oil, Xanthan Gum, Mentha Piperita (Peppermint Oil), Alcohol, Mica, Carrageenan, Sodium Gluconate, Sodium Hexametaphosphate, Citric Acid, Cocos Nucifera (Coconut) Oil, Disodium Pyophosphate, Stevia Rebaudiana Leaf/Stem Extract, Sucralose, Titanium Dioxide, Carvone, Vanillin, Sodium Sulfate, Gaultheria Procumbens (Wintergreen) Leaf Oil, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Propanediol, Magnesium Chloride, Sea Salt, Camellia Sinensis Extract, Myrciaria Dubia Fruit Extract, Echinacea Angustifolia Leaf Extract, Panax Ginseng Root Extract

Section 51945-4

Section 55105-1

Use: Aids in the prevention of dental cavities.

Section 55106-9

Active Ingredient: Sodium Fluoride 0.24% (0.14% w/v active fluoride ion) Anticavity

Structured Label Content

Indications and Usage (34067-9)

Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing.

Dosage and Administration (34068-7)

Directions:

Adults and children 2 years and older:

Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.

Do not swallow. To minimize swallowing use a pea-sized amount in children under 6.

Supervise children's brushing until good habits are established.

Children under 2 years ask a dentist.

Warnings and Precautions (34071-1)

Contains sodium fluoride. Children of 6 years and younger: Use a pea-sized amount with supervised brushin to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If more than used for brushin is accidentally swallowed, get medical help or contact a Poison Control Center right away. Children of 6 years and younger: Use a pea-sized amount with supervised brushin to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

Section 51727-6 (51727-6)

Hydrated Silica, Glycerin, Water, Sorbitol, Sodium Cocoyl Glutamate, Sodium Coco-Sulfate, Sodium Benzoate, MenthaArvensis Leaf Oil, Xanthan Gum, Mentha Piperita (Peppermint Oil), Alcohol, Mica, Carrageenan, Sodium Gluconate, Sodium Hexametaphosphate, Citric Acid, Cocos Nucifera (Coconut) Oil, Disodium Pyophosphate, Stevia Rebaudiana Leaf/Stem Extract, Sucralose, Titanium Dioxide, Carvone, Vanillin, Sodium Sulfate, Gaultheria Procumbens (Wintergreen) Leaf Oil, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Propanediol, Magnesium Chloride, Sea Salt, Camellia Sinensis Extract, Myrciaria Dubia Fruit Extract, Echinacea Angustifolia Leaf Extract, Panax Ginseng Root Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Use: Aids in the prevention of dental cavities.

Section 55106-9 (55106-9)

Active Ingredient: Sodium Fluoride 0.24% (0.14% w/v active fluoride ion) Anticavity

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:29.565829 · Updated: 2026-03-14T23:02:05.629064