Indications & Usage
Uses
- aids in the prevention of dental cavaties
- helps reducee painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Exceed Total Care Sensitive Paste, Dentifrice
FDA Label NDC 54473-340
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc for the product Exceed Total Care Sensitive (NDC 54473-340). 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 indications & usage, warnings, dosage & administration, inactive ingredient, otc - active ingredient, otc - keep out of reach of children, otc - when using, 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
Warnings
Warnings
- Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.
- Sensitivt teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.
Dosage & Administration
Directions
- adults and children 12 years of age or older: apply at least a 1-inch strup of the tooth polish onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Be sure to brush all sensitive areas of the teeth.
- children under 12 years of age: consult a dentist or doctor
Inactive Ingredient
Inactive Ingredients water, hydrated silica, glycerin, sorbitol, flavor, xanthan gum, stevia leaf extract, propanediol, poloxamer 407, zinc citrate, tetrasocium pyrophosphate, titanium dioxide, lauramidopropyl betaine, benzyl alcohol, sodium hydroxide, melaleuca alternifolia (tea tree) leaf oil.
Otc - Active Ingredient
Active Ingredient Purpose
Sodium fluoride (0.243%w/w)........................Anticavity
Potassium nitrate (5.0%w/w)...................Antisensitivity
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.
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