luster premium white

luster premium white
SPL v5
SPL
SPL Set ID e29f8a27-3a2f-4a48-9619-5154cbd9d406
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
glycerin sorbitol hydrated silica water xylitol cocamidopropyl betaine xanthan gum peppermint oil stevia rebaudiuna leaf tea tree oil mica titanium dioxide activated charcoal mentha arvensis leaf oil menthol vanilla bean

Identifiers & Packaging

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

ANTI-CAVITY

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

ANTI-CAVITY

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

Glycerin, Sorbitol, Hydrated Silica, Water (Aqua), Xylitol, Cocamidopropyl Betaine, Xanthan Gum, Mentha Piperita (Peppermint) Oil, Stevia Rebaudiana Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mica, Titanium Dioxide, Charcoal Powder, Mentha Arvensis (Cornmint) Leaf Oil, Menthol, Vanilla Planifolia Fruit Extract

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)

ANTI-CAVITY

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)

Glycerin, Sorbitol, Hydrated Silica, Water (Aqua), Xylitol, Cocamidopropyl Betaine, Xanthan Gum, Mentha Piperita (Peppermint) Oil, Stevia Rebaudiana Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mica, Titanium Dioxide, Charcoal Powder, Mentha Arvensis (Cornmint) Leaf Oil, Menthol, Vanilla Planifolia Fruit Extract

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: 2026-02-15T11:58:57.586463 · Updated: 2026-03-14T22:58:45.636917