THERABREATH FOR KIDS ANTICAVITY WACKY WATERMELON- sodium fluoride rinse 
THERABREATH FOR KIDS ANTICAVITY STRAWBERRY SPLASH- sodium fluoride rinse 
THERABREATH FOR KIDS ANTICAVITY GRAPES GALORE- sodium fluoride rinse 
Church & Dwight Co., Inc.

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 Anticavity Oral Rinse

Drug Facts

Active Ingredients

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. If more than used for rinsing is accidentally swallowed, get medical 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.

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, Xylitol, Citric Acid, Sucralose, Sodium Citrate

PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label - WACKY WATERMELON

ANTICAVITY FLUORIDE ORAL RINSE

TheraBreath™
for KIDS!

IT'S
SWISHY
TIME!™

DENTIST
FORMULATED

anti cavity

ORAL RINSE

Dr. Harold Katz

WACKY WATERMELON

Principal Display Panel - 296 mL Bottle Label - WACKY WATERMELON

PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label - STRAWBERRY SPLASH

ANTICAVITY FLUORIDE ORAL RINSE

TheraBreath™
for KIDS!

IT'S
SWISHY
TIME!™

DENTIST
FORMULATED

anti cavity

ORAL RINSE

Dr. Harold Katz

STRAWBERRY SPLASH

Principal Display Panel - 296 mL Bottle Label - STRAWBERRY SPLASH

PRINCIPAL DISPLAY PANEL - 296 mL Bottle Label - GRAPES GALORE

ANTICAVITY FLUORIDE ORAL RINSE

TheraBreath™
for KIDS!

IT'S
SWISHY
TIME!™

DENTIST
FORMULATED

anti cavity

ORAL RINSE

Dr. Harold Katz

GRAPES GALORE

Principal Display Panel - 296 mL Bottle Label - GRAPES GALORE
THERABREATH FOR KIDS ANTICAVITY WACKY WATERMELON 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-255
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorWATERMELONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-255-10296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2023
THERABREATH FOR KIDS ANTICAVITY STRAWBERRY SPLASH 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-256
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-256-10296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2023
THERABREATH FOR KIDS ANTICAVITY GRAPES GALORE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-257
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10237-257-10296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2023
Labeler - Church & Dwight Co., Inc. (001211952)

Revised: 12/2022
Document Id: 8cc2573d-ab5c-465f-a943-ffd399450c80
Set id: 578f8010-6b1c-4c6b-91d3-e483ace40f66
Version: 1
Effective Time: 20221228
 
Church & Dwight Co., Inc.