FDA Label for Therabreath Kids Anticavity Oral Rinse Bubblegum
View Indications, Usage & Precautions
Therabreath Kids Anticavity Oral Rinse Bubblegum Product Label
The following document was submitted to the FDA by the labeler of this product Church & Dwight Co., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
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
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