therabreath fresh breath

therabreath fresh breath
SPL v7
SPL
SPL Set ID 7c3a0bcc-a79f-c413-e053-2991aa0a7f51
Route
oral
Published
Effective Date 2019-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.0024 g)
Inactive Ingredients
spearmint mentha arvensis flower 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

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

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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 (OXYD-8™), Ammonium Glycyrrhizate, Ascorbic Acid (Vitamin C), 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)

Outer Packaging Box

Mild Mint Travel Size

Therabreath Fresh Breath


Structured Label Content

Warnings

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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 (OXYD-8™), Ammonium Glycyrrhizate, Ascorbic Acid (Vitamin C), 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)

Outer Packaging Box

Mild Mint Travel Size

Therabreath Fresh Breath (TheraBreath Fresh Breath)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)