THERABREATH PLUS FRESH BREATH- sodium fluoride paste, dentifrice 
Dr. Harold Katz, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TheraBreath Plus Fresh Breath

Active Ingredients

Sodium Fluoride 0.24%

(0.14% W/V fluoride ion)

Purpose

Anticavity Fluoride Dentrifice

Uses

Aids in the prevention of dental cavities

Warnings

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

Warnings

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

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

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)

TheraBreath Fresh Breath Label

Fresh Breath Toothpaste

THERABREATH PLUS FRESH BREATH 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72551-251
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0024 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
UBIDECARENONE (UNII: EJ27X76M46)  
SPEARMINT (UNII: J7I2T6IV1N)  
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
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)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
Product Characteristics
Colorwhite (Clear) Score    
ShapeSize
FlavorMINT (Mild Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72551-251-011 in 1 PACKAGE10/04/2018
1113.5 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:72551-251-0221.3 g in 1 TUBE; Type 0: Not a Combination Product10/04/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/04/2018
Labeler - Dr. Harold Katz, LLC (965507767)

Revised: 2/2022
Document Id: d723d2aa-6d99-6bd2-e053-2a95a90a9c75
Set id: 7c499cf1-bcac-2782-e053-2a91aa0a01bf
Version: 5
Effective Time: 20220203
 
Dr. Harold Katz, LLC