Otc - Active Ingredient
Stannous Fluoride 0.454% w/w (0.15% w/v fluoride ion) ...... Acticavity, Antigingivitis, Anithypersensitivity
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Rite Aid Sensitivity And Gum (NDC 11822-5060). 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, dosage & administration, indications & usage, otc - keep out of reach of children, otc - purpose, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Stannous Fluoride 0.454% w/w (0.15% w/v fluoride ion) ...... Acticavity, Antigingivitis, Anithypersensitivity
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.
Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto 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.
Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a poision control center right away.
Products containing stannous fluoride may produce surface staining of the teeth. Adquate 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 prevent staining. Store below 30C or 86F.
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.
glycerin, water, hydrated silica, petasodium tryiphosphate, flavor, sodium lauryl sulfate, titanium dioxide, cellulose gum, cocamiodpropyl betaine, sodium saccharin.
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