THERABREATH 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 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

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

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

Fresh Breath Label

Outer Packaging Box

Outer Box

Mild Mint Travel Size

Travel Size

THERABREATH FRESH BREATH 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72551-250
Route of AdministrationORAL
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
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
Colorwhite (Clear) Score    
ShapeSize
FlavorMINT (Mild Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72551-250-011 in 1 PACKAGE10/04/2018
1113.5 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:72551-250-0221.3 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: d7379de7-60a1-8e13-e053-2995a90a849f
Set id: 7c3a0bcc-a79f-c413-e053-2991aa0a7f51
Version: 7
Effective Time: 20220204
 
Dr. Harold Katz, LLC