Active Ingredient
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Therabreath Kids Anticavity Oral Rinse Bubblegum Rinse
FDA Label NDC 10237-266
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Therabreath Kids Anticavity Oral Rinse Bubblegum (NDC 10237-266). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Warnings
Warning
Otc - Keep Out Of Reach Of Children
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
Package Label.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
* Please review the disclaimer below.
