THERABREATH HEALTHY SMILE ORAL RINSE- sodium fluoride rinse 
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 Healthy Smile Oral Rinse

Active Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities

Warnings

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

Warnings

Directions

Adults and Children 6 years of age and older:

Other Information

Do not use if safety seal is broken or missing.

Inactive Ingredients

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Citric Acid, Sodium Hydroxide, Sodium Chlorite, Menthol, Citrus Lemon Peel Oil, Mentha Piperita Oil, Sodium Benzoate, Sucralose, Xylitol, Sodium Bicarbonate.

TheraBreath Healthy Smile Oral Rinse

Healthy Smile Oral Rinse

Healthy Smile Travel Size

Travel Size

Healthy Smile Travel Pouch 0.25 oz

Healthy Smile Travel Pouch 0.25 oz

THERABREATH HEALTHY SMILE ORAL RINSE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72551-246
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0005 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
LEMON OIL (UNII: I9GRO824LL)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MENTHOL (UNII: L7T10EIP3A)  
SODIUM CHLORITE (UNII: G538EBV4VF)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
Colorwhite (Clear) Score    
ShapeSize
FlavorMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72551-246-01473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
2NDC:72551-246-0285 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
3NDC:72551-246-037 g in 1 POUCH; Type 0: Not a Combination Product03/19/2019
4NDC:72551-246-04958.21 g in 1 BOTTLE; Type 0: Not a Combination Product10/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/02/2018
Labeler - Dr. Harold Katz, LLC (965507767)

Revised: 2/2022
Document Id: d7352a14-9f43-8d5b-e053-2995a90ab63b
Set id: 7f0e6864-5577-e368-e053-2a91aa0a57ca
Version: 8
Effective Time: 20220204
 
Dr. Harold Katz, LLC