Active Ingredients
Potassium Nitrate 5% Sodium Fluoride 0.240% (0.15% w/v Fluoride ion)
Potassium Nitrate 5% Sodium Fluoride 0.240% (0.15% w/v Fluoride ion)
4 Pack
FDA Label NDC 72164-101
12 label sections · Submitted to the FDA by Smiletwice, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smiletwice, Inc. for the product 4 Pack (NDC 72164-101). 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, purpose, uses, when using this product,, stop use and ask a dentist, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihypersensitivity
Anticavity
Antihypersensitivity
Anticavity
Uses
Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. Aids in prevention of dental cavities.
Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. Aids in prevention of dental cavities.
When Using This Product,
if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.
Stop Use And Ask A Dentist
if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
Keep Out Of Reach Of Children.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. · Children under 12 years: consult a dentist or doctor.
Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. · Children under 12 years: consult a dentist or doctor.
Inactive Ingredients
Water, Hydrated Silica, Sorbitol, Glycerin, Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Sodium Ascorbyl Phosphate (Vitamin C), Retinyl Palmitate (Vitamin A),Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.
Water, Hydrated Silica, Sorbitol, Glycerin, Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Sodium Acorbyl Phosphate (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.
When Using This Product
if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.
Stop Use And Ask A Dentist
if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
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