Sensitivity and Gum
5820069 Rexall Sensitivity & Gum
039c6e46-f995-c744-e063-6294a90a537e
HUMAN OTC DRUG LABEL
Aug 12, 2025
DG Health (Rexall)
DUNS: 068331990
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
Principal Display Panel
INDICATIONS & USAGE SECTION
Uses
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
INACTIVE INGREDIENT SECTION
Inactive ingredients
glycerin, water, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium saccharin
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion)
OTC - PURPOSE SECTION
Purpose
Anticavity, Antigingivitis, Antihypersensitivity
WARNINGS SECTION
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 SECTION
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 SECTION
Directions
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
Other 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 30C (86F)