H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]

H E B RESTORE AND DEFEND (FLUORIDE) PASTE, DENTIFRICE [HEB]
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NDC 37808-230-09, 37808-230-92
Set ID 56080493-9ab8-4b4f-be5f-7df22dee133f
Category HUMAN OTC DRUG LABEL
Packager HEB
Generic Name
Product Class
Product Number
Application Number PART355
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients

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

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  • PURPOSE

    Purpose

    Anticavity/Antihypersensitivity

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  • 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
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  • 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.

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  • 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.
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  • STORAGE AND HANDLING

    Other information

    products containing stannous fluoride may produce surface staining of the teeth. Adequate 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 30°C (86°)F
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  • INACTIVE INGREDIENT

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

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  • QUESTIONS

    Questions or Comments? CALL 1-877-777-2743

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  • SPL UNCLASSIFIED SECTION

    MADE WITH PRIDE AND CARE FOR H-E-B®

    SAN ANTONIO, TX 78204

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  • PRINCIPAL DISPLAY PANEL

    H-E-B®

    Fresh Mint

    SENSITIVE

    FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PROTECTION

    RESTORE & DEFEND

    • Daily protection for sensitive teeth
    • Removes stains for whiter teeth

    TWIN PACK

    2 Tubes of 3.4 OZ (96.3g); TOTAL NET WT. 6.8 OZ (192.6g)

    HEB RESTORE DEFEND 2PK 2821273R1

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  • INGREDIENTS AND APPEARANCE
    H E B  RESTORE AND DEFEND
    fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-230
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Product Characteristics
    Color white Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-230-09 1 in 1 CARTON 07/01/2014
    1 96.4 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:37808-230-92 2 in 1 CARTON 02/21/2019
    2 96.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 07/01/2014
    Labeler - HEB (007924756)
    Registrant - Lornamead Inc. (078584069)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead Inc. 078584069 manufacture(37808-230)
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