THERABREATH FRESH BREATH- sodium fluoride paste, dentifrice

TheraBreath Fresh Breath by

Drug Labeling and Warnings

TheraBreath Fresh Breath by is a Otc medication manufactured, distributed, or labeled by Dr. Harold Katz, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Sodium Fluoride 0.24%

(0.14% W/V fluoride ion)

Purpose

Anticavity Fluoride Dentrifice

Uses

Aids in the prevention of dental cavities

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.

Warnings

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

Warnings

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

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)

TheraBreath Fresh Breath

Outer Packaging Box

Mild Mint Travel Size

INGREDIENTS AND APPEARANCE

THERABREATH FRESH BREATH 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72551-250
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0024 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SPEARMINT (UNII: J7I2T6IV1N)
MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
SODIUM CHLORITE (UNII: G538EBV4VF)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor	MINT (Mild Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72551-250-01	1 in 1 PACKAGE	10/04/2018
1		113.5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 72551-250-02	21.3 g in 1 TUBE; Type 0: Not a Combination Product	10/04/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/04/2018

Labeler - Dr. Harold Katz, LLC (965507767)