therabreath plus fresh breath

therabreath plus fresh breath
SPL v5
SPL
SPL Set ID 7c499cf1-bcac-2782-e053-2a91aa0a01bf
Route
dental
Published
Effective Date 2018-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.0024 g)
Inactive Ingredients
ubidecarenone spearmint mentha arvensis leaf oil ascorbic acid ammonium glycyrrhizate sodium chlorite aloe vera leaf sodium benzoate potassium pyrophosphate sodium pyrophosphate carboxymethylcellulose sodium, unspecified form xylitol glycerin hydrated silica water sorbitol zinc gluconate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph final active Since 2018-10-04

Purpose

Anticavity Fluoride Dentrifice

Description

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


Medication Information

Warnings

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

Uses

Aids in the prevention of dental cavities

Purpose

Anticavity Fluoride Dentrifice

Directions

Adults & 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 or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

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

Sorbitol, Water (Aqua), Hydrated Silica, Glycerin (from vegetable sources), Xylitol, Natural Flavor, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Sodium Benzoate, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Chlorite, Zinc Gluconate, Ammonium Glycyrrhizate, Ascorbic Acid (Vitamin C), Ubiquinone (COQ10), Mentha Arvensis (Cornmint) Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Natural Fragrance (Parfum)

Description

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

Active Ingredients

Sodium Fluoride 0.24%

(0.14% W/V fluoride ion)

Therabreath Fresh Breath Label


Structured Label Content

Warnings

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

Uses

Aids in the prevention of dental cavities

Purpose

Anticavity Fluoride Dentrifice

Directions

Adults & 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 or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

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

Sorbitol, Water (Aqua), Hydrated Silica, Glycerin (from vegetable sources), Xylitol, Natural Flavor, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Sodium Benzoate, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Chlorite, Zinc Gluconate, Ammonium Glycyrrhizate, Ascorbic Acid (Vitamin C), Ubiquinone (COQ10), Mentha Arvensis (Cornmint) Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Natural Fragrance (Parfum)

Active Ingredients

Sodium Fluoride 0.24%

(0.14% W/V fluoride ion)

Therabreath Fresh Breath Label (TheraBreath Fresh Breath Label)


Advanced Ingredient Data


Raw Label Data

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