Active Ingredient
Sodium Fluoride....... 0.05%
(0.02% w/v fluoride ion)
The following Structured Product Label (SPL) was submitted to the FDA by Everbrands, Inc. for the product Eversmile Therafoam (NDC 72655-500). 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, uses, 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.
Sodium Fluoride....... 0.05%
(0.02% w/v fluoride ion)
Anticavity
•aids in the prevention of dental cavities
Stop use and ask dentist if oral irritation or tooth
sensitivity occurs
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.
To Brush:
•Dispense 1-2 pumps of foam onto a toothbrush.
Brush teeth, thoroughly, preferably
after each meal or at least twice a day, or as
directed by a dentist or physician
EverSmile Traybrush application:
•Adults and children 12 yrs. of age and older:
•Dispense 1-2 pumps of foam onto each side
of the TrayBrush.
•Insert the foam-filled Traybrush into your
mouth. Gently bite up and down, and move
the handle side to side for approximately
2 minutes to clean.
•If needed, remove the TrayBrush to spit out
excess foam- do not swallow, then reinsert
it immediately.
•Option: after brushing keep the TrayBrush in
contact with your teeth for up to 5 minutes
to enhance the therapeutic benefits.
•Use daily or as directed by your dentist.
•Children under 12 years of age: consult a
dentist or doctor
store at controlled room temperature
68-77°F(20-25°)
Water, hydrogen peroxide, PVP, PEG, glycerin, sucralose,
sodium lauryl sulfate, mentha arvensis (mint) oil, sodium
citrate, sodium benzoate
Questions? +1(855)595-2999
______________________________________
EverSmile®
THERAFOAM
THERAPEUTIC
ANTICAVITY
TOOTHFOAM
0.05% Sodium Fluoride 50 mL (1.69 fl oz)
Manufactured By
EverBrands, Inc
11791 Monarch St
Garden Grove,
CA 92841
(855)595-2999
eversmilewhite.com
RES
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