THERABREATH FOR KIDS ANTI CAVITY 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 for Kids Anti Cavity Oral Rinse

Active Ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

Keep Out Of Reach of Children.

Warnings

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

Directions

• Adults and children 6 years of age and older: Use once a day after brushing your teeth with a
toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not

swallow the rinse.
• Do not eat or drink for 30 minutes after rinsing.
• Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
Supervise children as necessary until capable of using without supervision.
• Children under 6 years of age: Consult a dentist or doctor.

Other information

Do not use if safety seal is broken or missing

Inactive Ingredients

Water, Glycerin, Sodium Benzoate, Flavor (Organic), Xylitol, Citric Acid, Sucralose, Sodium Citrate

TheraBreath Kids Anti Cavity Oral Rinse

Kids Anti Cavity Oral Rinse Label

THERABREATH FOR KIDS ANTI CAVITY ORAL RINSE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72551-254
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
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
GRAPE (UNII: 6X543N684K)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape (Organic)) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72551-254-01473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/01/2018
Labeler - Dr. Harold Katz, LLC (965507767)

Revised: 2/2022
Document Id: d7216ca6-f32b-c9e4-e053-2995a90a45d0
Set id: 7f34bc73-1940-07a7-e053-2a91aa0a1bfe
Version: 7
Effective Time: 20220203
 
Dr. Harold Katz, LLC