SPL v3
SPL
SPL Set ID 3582cc91-8c32-9f93-e063-6394a90a8792
Route
DENTAL
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-09
Description

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

Purpose

Anticavity toothpaste

Medication Information

Warnings and Precautions

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 42229-5

DISTR. LG H&H Co., Ltd.

58, SAEMUNAN-RO, JONGNO-GU, SEOUL, KKOREA

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.

Warnings and Precautions (34071-1)

Section 42229-5 (42229-5)

DISTR. LG H&H Co., Ltd.

58, SAEMUNAN-RO, JONGNO-GU, SEOUL, KKOREA

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: 2026-02-15T12:06:15.553015 · Updated: 2026-03-14T23:08:56.104871