Universal Anti-cavity Fluoride Toothpaste

SPL v2

SPL

SPL Set ID 421fc2f0-b118-4e7a-a399-ba4780028c54

Route

DENTAL

Published

Effective Date 2020-05-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.76 g)

Inactive Ingredients

Calcium Carbonate Water Glycerin Silicon Dioxide Sodium Lauryl Sulfate Sorbitol Xanthan Gum Saccharin Sodium Sodium Benzoate Carboxymethylcellulose Sodium, Unspecified Form

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-05-15

Description

Active Ingredient Sodium Monofluorophosphate 0.76% (1000 ppm)

Medication Information

Warnings and Precautions

Warning

Indications and Usage

Uses

regular brushing with flouride toothpaste helps protect teeth against cavities
aids in the prevention of dental cavities.

Dosage and Administration

Directions

adults and children of 2 years and older: brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist.
do not swallow.
to minimize swallowing, use a pea-sized amount in children under 6 years old.
supervise children's brushing until good habits are established.
children under 2 years: ask a dentist before use.

Children under 12 years of age: Consult a dentist or doctor

Description

Active Ingredient Sodium Monofluorophosphate 0.76% (1000 ppm)

Section 42229-5

Other information

store in a cool, dry place.

Section 50565-1

Keep out of reach of children under 6 years of age

If accidentally swallowed get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop and ask a dentist

if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7

When using this product

if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.

Section 51727-6

Inactive Ingredients

Calcium carbonate, Water, Glycerine, Silica, Sodium Lauryl sulphate, Sorbitol, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium carboxy methyl cellulose and Flavor

Section 51945-4

PRINCIPAL DISPLAY PANEL

ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1

Purpose

Anticavity toothpaste

Section 55106-9

Active Ingredient

Sodium Monofluorophosphate 0.76%

(1000 ppm)

Structured Label Content

Indications and Usage (34067-9)

Uses

regular brushing with flouride toothpaste helps protect teeth against cavities
aids in the prevention of dental cavities.

Dosage and Administration (34068-7)

Directions

adults and children of 2 years and older: brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist.
do not swallow.
to minimize swallowing, use a pea-sized amount in children under 6 years old.
supervise children's brushing until good habits are established.
children under 2 years: ask a dentist before use.

Children under 12 years of age: Consult a dentist or doctor

Warnings and Precautions (34071-1)

Warning

Section 42229-5 (42229-5)

Other information

store in a cool, dry place.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age

If accidentally swallowed get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop and ask a dentist

if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7 (50567-7)

When using this product

if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.

Section 51727-6 (51727-6)

Inactive Ingredients

Calcium carbonate, Water, Glycerine, Silica, Sodium Lauryl sulphate, Sorbitol, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium carboxy methyl cellulose and Flavor

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1 (55105-1)

Purpose

Anticavity toothpaste

Section 55106-9 (55106-9)

Active Ingredient

Sodium Monofluorophosphate 0.76%

(1000 ppm)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses regular brushing with flouride toothpaste helps protect teeth against cavities aids in the prevention of dental cavities.", "34068-7": "Directions adults and children of 2 years and older: brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist. do not swallow. to minimize swallowing, use a pea-sized amount in children under 6 years old. supervise children's brushing until good habits are established. children under 2 years: ask a dentist before use. Children under 12 years of age: Consult a dentist or doctor", "34071-1": "Warning", "42229-5": "Other information store in a cool, dry place.", "50565-1": "Keep out of reach of children under 6 years of age If accidentally swallowed get medical help or contact a Poison Control Center right away.", "50566-9": "Stop and ask a dentist if the problem persists or worsens. Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.", "50567-7": "When using this product if pain\\ sensitivity still persists after 4 weeks of use, please visit your dentist.", "51727-6": "Inactive Ingredients Calcium carbonate, Water, Glycerine, Silica, Sodium Lauryl sulphate, Sorbitol, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium carboxy methyl cellulose and Flavor", "51945-4": "PRINCIPAL DISPLAY PANEL ANTI-CAVITY FLUORIDE TOOTHPASTE", "55105-1": "Purpose Anticavity toothpaste", "55106-9": "Active Ingredient Sodium Monofluorophosphate 0.76% (1000 ppm)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:22.551545 · Updated: 2026-03-14T23:01:53.224533