SPL v2
SPL
SPL Set ID 300303e7-ef8b-7449-e063-6294a90ac811
Route
DENTAL
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Potassium Phosphate Poloxamer 407 Carrageenan Alpha-tocopherol Acetate Xanthan Gum Sucralose Glycerin Sodium Hexametaphosphate Thymol Red 33 Hydrated Silica Algin Blue 1 Lake Cocamidopropyl Betaine Zinc Stearate Titanium Dioxide Water Sodium Saccharin Eucalyptus Globulus Leaf Peg-6 Sodium Lauryl Sulfate Potassium Phosphate, Tribasic

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01
Description

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

Purpose

Anticavity toothpaste

Medication Information

Purpose

Anticavity toothpaste

Description

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

Use

helps protect against cavities

Do Not

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

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 directed 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 Ingredient

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, POTASSIUM PHOSPHATE, POLOXAMER 407, TITANIUM DIOXIDE, SODIUM SACCHARIN, ALGIN, BLUE 1 LAKE, TOCOPHERYL ACETATE, XANTHAN GUM, SUCRALOSE, RED 33, 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

Do Not (Do not)

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 directed 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 Ingredient (Active ingredient)

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, POTASSIUM PHOSPHATE, POLOXAMER 407, TITANIUM DIOXIDE, SODIUM SACCHARIN, ALGIN, BLUE 1 LAKE, TOCOPHERYL ACETATE, XANTHAN GUM, SUCRALOSE, RED 33, 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: 2026-02-15T12:06:02.263656 · Updated: 2026-03-14T23:08:29.204921