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

TheraBreath for Kids Anticavity Grapes Galore by

Drug Labeling and Warnings

TheraBreath for Kids Anticavity Grapes Galore by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

• 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, 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 - 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 - GRAPES GALORE

ANTICAVITY FLUORIDE ORAL RINSE

TheraBreath ™
for KIDS!

IT'S
SWISHY
TIME!™

DENTIST
FORMULATED

anti cavity

ORAL RINSE

Dr. Harold Katz

GRAPES GALORE

INGREDIENTS AND APPEARANCE

THERABREATH FOR KIDS ANTICAVITY WACKY WATERMELON 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-255
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	WATERMELON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-255-10	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2023
2	NDC: 10237-255-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/01/2023

THERABREATH FOR KIDS ANTICAVITY STRAWBERRY SPLASH 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-256
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-256-10	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2023
2	NDC: 10237-256-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/01/2023

THERABREATH FOR KIDS ANTICAVITY GRAPES GALORE 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-257
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-257-10	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2023
2	NDC: 10237-257-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/01/2023

Labeler - Church & Dwight Co., Inc. (001211952)