THERABREATH KIDS ANTICAVITY ORAL RINSE BUBBLEGUM- anticavity oral rinse rinse

TheraBreath Kids Anticavity Oral Rinse Bubblegum by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Anticavity

USE

aids in the prevention of dental cavities

WARNINGS

Warning

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 spitout
do not swallow the rinse
do not eat or drink for30 minutes after rinsing
instruct children under 12 years of age in good rinsing
habits (to minimize swallowing)
supervise childrenas necessary until capableof 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, flavor (organic), potassium sorbate,citric acid, sodium citrate, sodium bicarbonate, cetylpyridinium chloride, sucralose

PRINCIPAL DISPLAY PANEL

STRENGTHENS TEETH & ENAMEL

TheraBreath

KIDS

DENTIST FORMULATED

ANTICAVITY

FLUORIDE ORAL RINSE

Dr. Harold Katz

Bubblegum Blast

No DYES

ALCOHOL-FREE

IMPORTANT: Read direcations for proper use.

16 fl. oz. (1 pt.) 473 mL

INGREDIENTS AND APPEARANCE

THERABREATH KIDS ANTICAVITY ORAL RINSE BUBBLEGUM 
anticavity oral rinse rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-266
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.005 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-266-10	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/31/2024
2	NDC: 10237-266-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/31/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	12/31/2024

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