Active Ingredients(In Each Tablet) Purpose
Sodium fluoride 1.54mg (0.7mg fluoride ion) anticavity
Tidalove Smile More Oral Care
FDA Label NDC 82756-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Paranmare for the product Tidalove Smile More Oral Care (NDC 82756-002). 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 ingredients(in each tablet) purpose, inactive ingredients, otc - purpose, otc - when using, otc - keep out of reach of children, otc - ask doctor, warnings, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
silicon dioxide, tetrasodium pyrophosphate, pyridoxine hydrochloride(vitamin B6), D-sorbitol, microcrystalline cellulose, xylitol, enzymatically modified stevia, bamboo salt, hydroxypropylcellulose, xanthan gum, sodium cocoyl glutamate, sodium bicarbonate, magnesium stearate, hydroxyapatite, tocopherol acetate(vitamin E), sodium ascorbate (vitamin C), L-menthol, combined flavor, green tea extract, eucalyptus oil, rosemary extract
Otc - Purpose
Aids in the prevention of dental cavities
Otc - When Using
▪ Adults and children 6 years of age and older: Chew 1 tablet until crushed.
▪ Brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician.
▪ Spit out: Do not swallow the tablet.
▪ Children under 6 years of age should be supervised when using this product.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Otc - Ask Doctor
Brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Warnings
Do not use it for anything other than brushing teeth, and be careful not to swallow it.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.Keep out of the reach of children.
Small tablets may be a chocking hazard for children under 3 years old.
Keep it away from the pets.
When using this product, if irritation or sensitivity occurs, discontinue use.
Otc - Do Not Use
When using this product, if irritation or sensitivity occurs, discontinue use.
Other Safety Information
Store at 25-30 °C (68-77°F). Protect from excessive moisture.
Dosage & Administration
Gently chew 1 tablet until it crushed. Brush teeth thoroughly,
Indications & Usage
Adults and children 6 years of age and older: Chew 1 tablet until crushed.
Brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician.
Spit out: Do not swallow the tablet.
Children under 6 years of age should be supervised when using this product.
Package Label.Principal Display Panel
Outer Package (Tidalove1)
Outer Package (Tidalove2)
Drug Facts (0002)
Drug Facts (0001)
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