Rite Aid Sensitivity and Gum
5820060 Rite Aid Sensitivity and Gum (8015053)
ed362e9c-2dab-1102-e053-2a95a90a76f3
HUMAN OTC DRUG LABEL
Aug 12, 2025
Rite Aid
DUNS: 014578892
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Stannous Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
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.
OTC - ACTIVE INGREDIENT SECTION
Stannous Fluoride 0.454% w/w (0.15% w/v fluoride ion) ...... Acticavity, Antigingivitis, Anithypersensitivity
DOSAGE & ADMINISTRATION SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
OTC - PURPOSE SECTION
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.
WARNINGS SECTION
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.
INACTIVE INGREDIENT SECTION
glycerin, water, hydrated silica, petasodium tryiphosphate, flavor, sodium lauryl sulfate, titanium dioxide, cellulose gum, cocamiodpropyl betaine, sodium saccharin.