luster premium white pearl

luster premium white pearl
SPL v4
SPL
SPL Set ID b7742579-65c6-4ebf-b369-eeacaefd7da5
Route
dental
Published
Effective Date 2020-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (.24 g)
Inactive Ingredients
sorbitol hydrated silica water propylene glycol sodium lauroyl sarcosinate copovidone k25-31 sodium phosphate, dibasic, anhydrous mica carboxymethylcellulose sodium, unspecified sodium benzoate potassium acetate titanium dioxide xanthan gum sodium pyrophosphate calcium carbonate

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2020-10-23
Purpose

ANTICAVITY

Description

SODIUM FLUORIDE 0.24% (0.15% W/V FLUORIDE ION)

Medication Information

Warnings

If you accidentally swallow more than used for brushing, get medical help,

Purpose

ANTICAVITY

Directions
  • Adults and children 6 years of age and older—Brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by adentist or doctor.
  • Children 6 to 12 years—Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 6 years—Do not use unless directed by dentist or physician.

Inactive Ingredients

Sorbitol, Hydrated Silica, Water, Propylene Glycol, Sodium Lauroyl Sarcosinate, Flavor, Pvm/Ma Copolymer, Disodium Phosphate, Mica, Cellulose Gum, Sodium Benzoate, Potassium Acesulfame, Titanium Dioxide, Xanthan Gum, Tetrasodium Pyrophosphate, Hydrolyzed Pearl

Description

SODIUM FLUORIDE 0.24% (0.15% W/V FLUORIDE ION)

Use

HELPS PROTECT AGAINST CAVITIES.

Section 50565-1

Keep out of reach of children under 6 years of age.

Section 51945-4

Questions

1-800-823-5272 | French Transit, Ltd., Louisville, CO 80027 USA

*Visit LusterPremiumWhite.com for more information.

Active Ingredient

SODIUM FLUORIDE 0.24% (0.15% W/V FLUORIDE ION)

Structured Label Content

Warnings (WARNINGS)

If you accidentally swallow more than used for brushing, get medical help,

Purpose (PURPOSE)

ANTICAVITY

Directions (DIRECTIONS)
  • Adults and children 6 years of age and older—Brush teeth thoroughly, preferably after each meal, at least twice daily, or as directed by adentist or doctor.
  • Children 6 to 12 years—Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
  • Children under 6 years—Do not use unless directed by dentist or physician.

Inactive Ingredients (INACTIVE INGREDIENTS)

Sorbitol, Hydrated Silica, Water, Propylene Glycol, Sodium Lauroyl Sarcosinate, Flavor, Pvm/Ma Copolymer, Disodium Phosphate, Mica, Cellulose Gum, Sodium Benzoate, Potassium Acesulfame, Titanium Dioxide, Xanthan Gum, Tetrasodium Pyrophosphate, Hydrolyzed Pearl

Use (USE)

HELPS PROTECT AGAINST CAVITIES.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.

Section 51945-4 (51945-4)

Questions (QUESTIONS)

1-800-823-5272 | French Transit, Ltd., Louisville, CO 80027 USA

*Visit LusterPremiumWhite.com for more information.

Active Ingredient (ACTIVE INGREDIENT)

SODIUM FLUORIDE 0.24% (0.15% W/V FLUORIDE ION)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:57.583169 · Updated: 2026-03-14T22:58:45.636917