SPL v6
SPL
SPL Set ID d9609989-2a4a-4357-aea8-44ee95aba524
Route
ORAL
Published
Effective Date 2021-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 g)
Inactive Ingredients
Sodium Pyrophosphate .alpha.-tocopherol Acetate Sorbitol Xylitol Hydrated Silica Sodium Lauryl Sulfate Menthol, Unspecified Form Matricaria Chamomilla Whole Ginger Tea Tree Oil Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-06-15
Description

Sodium Fluoride 0.02%

Purpose

Anticavity Toothpaste

Medication Information

Purpose
  • Anticavity Toothpaste
Description

Sodium Fluoride 0.02%

Use
  • Aids in the prevention of dental cavities
Warnings
  • Be careful not to swallow. Rinse mouth thoroughly after use.
  • If pain occurs when using this product, stop using and consult your dentist.
  • For children under 6 years of age, use a pea size amount of toothpaste as recommended by the KFDA. Use under the guidance of a guardian.
  • If a child under 6 years old swallows a large amount, consult a physician or dentist immediately.
  • Keep out of the reach of children under 6 years old.
Directions
  • Apply appropriate amount on a toothbrush and brush teeth.
Product Label

Effect Efficacy
  • Whitens teeth while fighting germs
  • Long-lasting freshness and clean mouth feel
  • Protects against cavities and bad breath
  • Natural brightness of your teeth shines
  • Anti plaque
  • Helps prevent plaque, gingivitis cavities and gum disease
Active Ingredient

Sodium Fluoride 0.02%

Inactive Ingredients

Silica,Sorbitol, Tetrasodium Pyrophosphate, Tocopheryl Acetate,

Xylitol, Glucosyl Stevioside, Hydrated Silica, Cellulose Gum, Sodium lauryl Sulfate, Menthol,

Chamomilla Recutita (Matricaria) Extract, Artemisia Princeps Extract, Zingiber Officinale (Ginger) Root Extract,

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Flavor, Gardenia Red, Water

Structured Label Content

Use
  • Aids in the prevention of dental cavities
Purpose
  • Anticavity Toothpaste
Warnings
  • Be careful not to swallow. Rinse mouth thoroughly after use.
  • If pain occurs when using this product, stop using and consult your dentist.
  • For children under 6 years of age, use a pea size amount of toothpaste as recommended by the KFDA. Use under the guidance of a guardian.
  • If a child under 6 years old swallows a large amount, consult a physician or dentist immediately.
  • Keep out of the reach of children under 6 years old.
Directions
  • Apply appropriate amount on a toothbrush and brush teeth.
Product Label (Product label)

Effect Efficacy (Effect- Efficacy)
  • Whitens teeth while fighting germs
  • Long-lasting freshness and clean mouth feel
  • Protects against cavities and bad breath
  • Natural brightness of your teeth shines
  • Anti plaque
  • Helps prevent plaque, gingivitis cavities and gum disease
Active Ingredient (Active ingredient)

Sodium Fluoride 0.02%

Inactive Ingredients (Inactive ingredients)

Silica,Sorbitol, Tetrasodium Pyrophosphate, Tocopheryl Acetate,

Xylitol, Glucosyl Stevioside, Hydrated Silica, Cellulose Gum, Sodium lauryl Sulfate, Menthol,

Chamomilla Recutita (Matricaria) Extract, Artemisia Princeps Extract, Zingiber Officinale (Ginger) Root Extract,

Melaleuca Alternifolia (Tea Tree) Leaf Oil, Flavor, Gardenia Red, Water

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:03.015793 · Updated: 2026-03-14T23:04:28.287489