SPL v3
SPL
SPL Set ID 7f34abc2-af6d-0bb2-e053-2991aa0a04ab
Route
DENTAL
Published
Effective Date 2018-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.0024 g)
Inactive Ingredients
Water Sorbitol Xylitol Hydrated Silica Glycerin Sodium Lauroyl Sarcosinate Potassium Pyrophosphate Zinc Gluconate Sodium Pyrophosphate Sodium Chlorite Mentha Piperita Aloe Vera Leaf Sodium Benzoate Ubidecarenone

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-10-01

Description

Sodium fluoride 0.24% (0.14% W/V fluoride ion)

Purpose

Anticavity Fluoride Dentrifice


Medication Information

Purpose

Anticavity Fluoride Dentrifice

Description

Sodium fluoride 0.24% (0.14% W/V fluoride ion)

Uses

Aids in the prevention of dental cavities

Warnings

If more than used for brushing is accidentally

swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Sodium fluoride 0.24%

(0.14% W/V fluoride ion)

Other Information
  • If spilled on fabrics, wash out immediately.
  • This product was sealed with protective packaging at

the laboratory.

• If seal is missing, do not use.

Inactive Ingredients

Water (Aqua), Hydrated Silica, Sorbitol, Glycerin, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Xylitol, Sodium Lauroyl Sarcosinate, Sodium Chlorite (PeriO2), Mentha Piperita (Peppermint) Oil, Zinc Gluconate (ZincRx), Aloe Barbadensis Leaf Juice, Sodium Benzoate, Ubiquinone.

Therabreath Perio Therapy Healthy Gums Toothpaste


Structured Label Content

Uses

Aids in the prevention of dental cavities

Purpose

Anticavity Fluoride Dentrifice

Warnings

If more than used for brushing is accidentally

swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredient

Sodium fluoride 0.24%

(0.14% W/V fluoride ion)

Other Information (Other information)
  • If spilled on fabrics, wash out immediately.
  • This product was sealed with protective packaging at

the laboratory.

• If seal is missing, do not use.

Inactive Ingredients

Water (Aqua), Hydrated Silica, Sorbitol, Glycerin, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Xylitol, Sodium Lauroyl Sarcosinate, Sodium Chlorite (PeriO2), Mentha Piperita (Peppermint) Oil, Zinc Gluconate (ZincRx), Aloe Barbadensis Leaf Juice, Sodium Benzoate, Ubiquinone.

Therabreath Perio Therapy Healthy Gums Toothpaste (TheraBreath Perio Therapy Healthy Gums Toothpaste)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)