Label: SENSITIVE RAPID RELIEF- stannous fluoride paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 14, 2024

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion) . . . Anticavity/Antihypersensitivity

  • PURPOSE

    Uses

    aids in teh prevention of dental cavities * 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 doctor 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

    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.

  • Directions

    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 one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. * Do not swallow * 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 toothbrushing 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, cellulose gum, cocomidopropyl betaine, titanium dioxide, sodium lauryl sulfate, sodium saccharin

  • PRINCIPAL DISPLAY PANEL

    Carton R3

  • INGREDIENTS AND APPEARANCE
    SENSITIVE RAPID RELIEF 
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0014
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    Colorwhite (White to off white) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0014-91 in 1 CARTON06/02/2020
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02106/02/2020
    Labeler - Rite Aid (014578892)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(11822-0014)
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