Otc - Active Ingredient
Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion)
Cvs Sens Whtng Paste, Dentifrice
FDA Label NDC 69842-563
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Cvs Sens Whtng (NDC 69842-563). 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, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anticavity, Antigingivitis, Antihypersensitivity
Indications & Usage
aids in the prevention of dental cavities * helps interfere with the harmful effects of plaque associated with gingivitis * builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
Warnings
When using this product, if irritation occurs discontinue use.
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 * pain/sensitivity still persists after 4 weeks of use * gingivitis, bleeding, or redness persists for more than 2 weeks * you have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than is used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
adults and children 12 years of age and older: apply at least a 1-inch strip of the product unto a soft bristle toothbrush * brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. * children under 12 years of age: consult a dentist or doctor.
Other Safety Information
products containing stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. * this product is specifically formulated to help prevent staining. * store below 30*C (86*F)
Inactive Ingredient
glycerin, water, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium saccharin
* Please review the disclaimer below.
