Smarth™ - DailyMed Details

Smarth™

SPL v1

SPL

SPL Set ID e0e06db3-70bf-497f-a0fd-b7439fa23834

Route

DENTAL

Published

Effective Date 2013-12-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (7.6 mg)

Inactive Ingredients

Sorbitol Hydrated Silica Water Sodium Lauryl Sulfate Sodium Bicarbonate Sodium Benzoate Saccharin Sodium Carboxymethylcellulose Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2013-12-01

Description

Drug Facts

Purpose

AntiCavity Toothpaste

Medication Information

Purpose

AntiCavity Toothpaste

Description

Drug Facts

Use

aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

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 immediately

Directions

Do not swallow
Supervise children as necessary until capable of using without supervision
Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
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 doctor
Children under 6 years of age: Do not use unless directed by a doctor or dentist

Active Ingredient

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Inactive Ingredients

Sorbitol, Hydrated Silica, Demineralized Water, Sodium Lauryl Sulphate, Sodium Bicarbonate, Sod. CMC, Flavor, Sodium Benzoate, Sodium Saccharin

Principal Display Panel 181g Tube Carton

SMARTH™

Extra Strength Fluoride Toothpaste

BAKING SODA

NET WT 6.4 Oz [181g]

Structured Label Content

Use

aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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 immediately

Purpose

AntiCavity Toothpaste

Directions

Do not swallow
Supervise children as necessary until capable of using without supervision
Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing)
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 doctor
Children under 6 years of age: Do not use unless directed by a doctor or dentist

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Inactive Ingredients

Sorbitol, Hydrated Silica, Demineralized Water, Sodium Lauryl Sulphate, Sodium Bicarbonate, Sod. CMC, Flavor, Sodium Benzoate, Sodium Saccharin

Principal Display Panel 181g Tube Carton (PRINCIPAL DISPLAY PANEL - 181g Tube Carton)

SMARTH™

Extra Strength Fluoride Toothpaste

BAKING SODA

NET WT 6.4 Oz [181g]

Advanced Ingredient Data

[{"name": "Fluoride ion", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "7.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Sorbitol", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hydrated Silica", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Lauryl Sulfate", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Bicarbonate", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Benzoate", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Saccharin Sodium", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Carboxymethylcellulose Sodium", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "42229-5": "Drug Facts", "50565-1": "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 immediately", "Purpose": "AntiCavity Toothpaste", "Directions": "Do not swallow Supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) 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 doctor Children under 6 years of age: Do not use unless directed by a doctor or dentist", "Active ingredient": "Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)", "Inactive Ingredients": "Sorbitol, Hydrated Silica, Demineralized Water, Sodium Lauryl Sulphate, Sodium Bicarbonate, Sod. CMC, Flavor, Sodium Benzoate, Sodium Saccharin", "PRINCIPAL DISPLAY PANEL - 181g Tube Carton": "SMARTH ™ Extra Strength Fluoride Toothpaste BAKING SODA NET WT 6.4 Oz [181g]"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:43.445737 · Updated: 2026-03-14T22:53:38.485484