Smarth™

Smarth™
SPL v1
SPL
SPL Set ID 0599719b-ea4b-42b5-8f6b-182e39ddefa3
Route
DENTAL
Published
Effective Date 2013-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg)
Inactive Ingredients
Calcium Carbonate Sorbitol Water Sodium Lauryl Sulfate Hydrated Silica Sodium Silicate 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

Calcium Carbonate, Sorbitol, Demineralized Water, Sodium Lauryl Sulphate, Hydrated Silica, Sod. CMC, Flavor, Sodium Silicate, Sodium Benzoate, Sodium Saccharin

Principal Display Panel 181g Tube Carton

SMARTH ™

Extra Strength Fluoride Toothpaste

MINTY FRESH

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

Calcium Carbonate, Sorbitol, Demineralized Water, Sodium Lauryl Sulphate, Hydrated Silica, Sod. CMC, Flavor, Sodium Silicate, Sodium Benzoate, Sodium Saccharin

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

SMARTH ™

Extra Strength Fluoride Toothpaste

MINTY FRESH

NET WT 6.4 Oz [181g]

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:43.435484 · Updated: 2026-03-14T22:53:38.485484