THERABREATH FRESH BREATH ANTICAVITY MILD MINT- sodium fluoride paste, dentifrice

TheraBreath Fresh Breath Anticavity Mild Mint by

Drug Labeling and Warnings

TheraBreath Fresh Breath Anticavity Mild Mint by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., Strukmyer Medical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

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

Purpose

Anticavity

Uses

Aids in the prevention of dental decay.

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Do not swallow.

Supervise children as necessary until capable of using without supervision.

Adults and children 6 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 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by 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, Hydrated Silica, Glycerin, Xylitol, Natural Flavors, Cellulose Gum, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Ammonium Glycyrrhizate, Sodium Benzoate, Citric Acid, Sodium Chlorite, Aloe Barbadensis Leaf Juice, Ascorbic Acid (Vitamin C).

PRINCIPAL DISPLAY PANEL - 113.5 g Tube Carton

DENTIST FORMULATED
FIGHTS CAVITIES
FIGHTS BAD BREATH FOR 12H*

ANTICAVITY FLUORIDE TOOTHPASTE

TheraBreath™
DENTIST FORMULATED
FRESH BREATH
TOOTHPASTE

FIGHTS CAVITIES
FIGHTS BAD BREATH FOR 12 HOURS*

AntiCavity
With Aloe Vera

Net Wt. 4 oz. 113.5 g

MILD MINT

Read back panel for current directions

FIGHTS BAD BREATH FOR 12 HOURS*

INGREDIENTS AND APPEARANCE

THERABREATH FRESH BREATH ANTICAVITY MILD MINT 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-263
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORITE (UNII: G538EBV4VF)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-263-04	1 in 1 CARTON	02/08/2024
1		113.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	02/08/2024

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Strukmyer Medical		078587210	MANUFACTURE(10237-263)