Otc - Active Ingredient
sodium fluoride
Truwell Dentiwash
FDA Label NDC 61284-0013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ecoworldpharm Co.,ltd for the product Truwell Dentiwash (NDC 61284-0013). 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 otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
purified water, glycerin, xylitol, green tea extract, acetic acid, strawberry flavoring, sodium acetate, grapefruit seed extract, sodium benzoate, L-menthol, sodium saccharin, chitosan
Otc - Purpose
aids in the prevention of dental cavities
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF THE CHILDREN
Indications & Usage
Adults and children 6 years of age and older:
use twoce a day after brishing your teeth with a toothpaste
vigorously swish contents of one (1) 11mL packet 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 uder 6 years of age: consult a dentist or doctor
Warnings
if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
for dental use only
Package Label.Principal Display Panel
Label (Label)
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