Label: CARE ONE RESTORE AND DEFEND SENSITIVE WHITENING- stannous fluoride paste, dentifrice

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

Drug Label Information

Updated February 12, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Stannous Fluoride 0.454% w/w (0.15% fluoride ion)

  • PURPOSE

    Purpose

    Anticavity/Antihypersensitivity

  • INDICATIONS & USAGE

    Uses

    • aids in the prevention of dental cavities
    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • WARNINGS

    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

    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.

  • DOSAGE & ADMINISTRATION

    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 directed 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
  • STORAGE AND HANDLING

    Other 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

    Inactive ingredients glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

  • QUESTIONS

    Questions or Comments? CALL 1-877-846-9949

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    For product questions or concerns, contact us at 1-877-849-9949

  • PRINCIPAL DISPLAY PANEL

    CareOne®

    RESTORE & DEFEND SENSITIVE TOOTHPASTE

    FOR SENSITIVE TEETH & CAVITY PROTECTION

    DAILY PROTECTION FOR SENSITIVE TEETH

    WHITENING

    FRESH MINT

    NET WT 3.4 OZ (96.3 g)

    CareOne_RestoreDefend_Carton_2821293R1

  • INGREDIENTS AND APPEARANCE
    CARE ONE RESTORE AND DEFEND  SENSITIVE WHITENING
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-722
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-722-191 in 1 CARTON02/11/2019
    196.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/11/2019
    Labeler - Foodhold U.S.A. (809183973)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(41520-722)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!