Smilebar Whitening Toothpaste

Smilebar Whitening Toothpaste
SPL v3
SPL
SPL Set ID 5c475cee-6e7e-423f-8945-de99b5458681
Route
DENTAL
Published
Effective Date 2020-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.43 mg)
Inactive Ingredients
Glycerin Water Hydrated Silica Sodium Lauryl Sulfate Sodium Bicarbonate Polyethylene Glycol 8000 Carboxymethylcellulose Saccharin Sodium Zinc Citrate Sucralose Titanium Dioxide Tricalcium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-11-15
Description

Drug facts

Medication Information

Warnings and Precautions

Warnings: Keep out of reach of children under 6 yrs. of age.

If large amount (more than would be used for brushing) is swallowed, get medical help, or contact a Poison Control Center right away.

Indications and Usage

Uses

Helps protect against cavities

Dosage and Administration

Directions

  • Brush teeth thoroughly after

    meals or at least two times a day

   (or use as directed by a dentist)

  • Do not swallow
  • Not for children undre 6

Description

Drug facts

Section 42229-5

Drug facts

Section 50565-1

Section 51727-6

Inactive ingredients:  Glycerin, Water,

Hydrated Silica, Sodium Lauryl Sulfate,

Sodium Bicarbonate, PEG, CMC, Sodium

Saccharin, Zinc Citrate, Flavor, Sucralose,

Titanium Dioxide, Tri-calcium Phosphate

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active ingredient

Sodium Fluoride 0.243%

Package Labeling

      WHITENING TOOTHPASTE

WITH FLUORIDE + BAKING SODA

DESIGNED FOR CLEAR ALIGNER TREATMENT

      WHITENS                 PROTECTS GUMS

FIGHTS CAVITIES      RESTORES ENAMEL

NET WT 3.4 OZ  e96 G

      WHITENS TEETH BY REMOVING

SURFACE STAINS, TARTER, AND PLAQUE               SMILEBAR.COM

Distributed by SMILEBAR

303 Columbus Ave

Boston, MA 02116

res

Structured Label Content

Indications and Usage (34067-9)

Uses

Helps protect against cavities

Dosage and Administration (34068-7)

Directions

  • Brush teeth thoroughly after

    meals or at least two times a day

   (or use as directed by a dentist)

  • Do not swallow
  • Not for children undre 6

Warnings and Precautions (34071-1)

Warnings: Keep out of reach of children under 6 yrs. of age.

If large amount (more than would be used for brushing) is swallowed, get medical help, or contact a Poison Control Center right away.

Section 42229-5 (42229-5)

Drug facts

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Inactive ingredients:  Glycerin, Water,

Hydrated Silica, Sodium Lauryl Sulfate,

Sodium Bicarbonate, PEG, CMC, Sodium

Saccharin, Zinc Citrate, Flavor, Sucralose,

Titanium Dioxide, Tri-calcium Phosphate

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium Fluoride 0.243%

Package Labeling

      WHITENING TOOTHPASTE

WITH FLUORIDE + BAKING SODA

DESIGNED FOR CLEAR ALIGNER TREATMENT

      WHITENS                 PROTECTS GUMS

FIGHTS CAVITIES      RESTORES ENAMEL

NET WT 3.4 OZ  e96 G

      WHITENS TEETH BY REMOVING

SURFACE STAINS, TARTER, AND PLAQUE               SMILEBAR.COM

Distributed by SMILEBAR

303 Columbus Ave

Boston, MA 02116

res

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:07.131517 · Updated: 2026-03-14T22:58:59.398920