Bright Smiles

Bright Smiles
SPL v1
SPL
SPL Set ID dcf7a177-c353-4d4f-aab3-c58f574be11c
Route
DENTAL
Published
Effective Date 2017-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 g)
Inactive Ingredients
Sorbitol Water Hydrated Silica Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Form Saccharin Sodium Methylparaben Sodium Propylparaben Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-05-15
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 accidently 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 a doctor.
  • Children under 2 years of age: Consult a dentist doctor.
Active Ingredient

Sodium Fluoride 0.22%

(0.1% w/v fluoride ion)

Inactive Ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharin, sodium methyl paraben, sodium propyl paraben.

Principal Display Panel 42 G Tube Label

BrightSmiles

Fluoride Gel Toothpaste

NET WT. 1.5 oz (42g)

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 accidently 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 a doctor.
  • Children under 2 years of age: Consult a dentist doctor.
Active Ingredient (Active ingredient)

Sodium Fluoride 0.22%

(0.1% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharin, sodium methyl paraben, sodium propyl paraben.

Principal Display Panel 42 G Tube Label (PRINCIPAL DISPLAY PANEL - 42 g Tube Label)

BrightSmiles

Fluoride Gel Toothpaste

NET WT. 1.5 oz (42g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:15.325598 · Updated: 2026-03-14T22:54:36.982637