SPL v3
SPL
SPL Set ID 369aa02f-c312-6a0d-e063-6294a90adaa5
Route
DENTAL
Published
Effective Date 2025-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Xanthan Gum Glycerin Thymol Cocamidopropyl Betaine Sucralose Potassium Phosphate, Tribasic .alpha.-tocopherol Acetate Eucalyptus Globulus Leaf Algin Poloxamer 407 Zinc Stearate Yellow 6 Potassium Phosphate Titanium Dioxide Sodium Saccharin Sodium Lauryl Sulfate Red 33 Peg-6 Hydrated Silica Carrageenan Sodium Hexametaphosphate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-07
Description

Sodium Fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

Anticavity toothpaste

Medication Information

Purpose

Anticavity toothpaste

Dosage and Administration

Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately.

Description

Sodium Fluoride 0.243% (0.15% w/v fluoride ion)

Use

helps protect against cavities

Section 51945-4

Directions
  • adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directly by a dentist.
  • do not swallow.
  • to minimize swallowing use a pea-sized amount in children under 6.
  • supervise children's brushing until good habits are established.
  • children under 2 years: ask a dentist
Questions?

1-866-993-4709

Active Ingredients

Sodium Fluoride 0.243%

(0.15% w/v fluoride ion)

Inactive Ingredients

Glycerin, Hydrated Silica, Sodium Hexametaphosphate, Water, Flavor/Aroma, PEG-6, Zinc Stearate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Tripotassium Phosphate, Carrageenan, Titanium Dioxide, Potassium Phosphate, Poloxamer 407, Sodium Saccharin, Algin, Tocopheryl Acetate, Xanthan Gum, Sucralose, D&C Red 33(CI 17200), FD&C Yellow 6(CI 15985), Eucalyptus Globulus Leaf Extract, Thymol

Keep Out of Reach of Children

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

Structured Label Content

Use

helps protect against cavities

Dosage and Administration (34068-7)

Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately.

Section 51945-4 (51945-4)

Purpose

Anticavity toothpaste

Directions
  • adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directly by a dentist.
  • do not swallow.
  • to minimize swallowing use a pea-sized amount in children under 6.
  • supervise children's brushing until good habits are established.
  • children under 2 years: ask a dentist
Questions?

1-866-993-4709

Active Ingredients

Sodium Fluoride 0.243%

(0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Glycerin, Hydrated Silica, Sodium Hexametaphosphate, Water, Flavor/Aroma, PEG-6, Zinc Stearate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Tripotassium Phosphate, Carrageenan, Titanium Dioxide, Potassium Phosphate, Poloxamer 407, Sodium Saccharin, Algin, Tocopheryl Acetate, Xanthan Gum, Sucralose, D&C Red 33(CI 17200), FD&C Yellow 6(CI 15985), Eucalyptus Globulus Leaf Extract, Thymol

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:28.261886 · Updated: 2026-03-14T23:09:15.187219